Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680602

FEI Number

1000268645

Entity Name

PALL NEWQUAY

City/State/Country

Newquay Cornwall, GB

Establishment Address

ST. COLUMB MAJOR, Newquay Cornwall TR9 6TT, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pall Medical (Owner Number: 2410597)

Owner / Operator Contact Address

C/O Global Life Sciences Solutions USA LLC, 100 Results Way, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993379

PMA Number

N/A

All Registered Proprietary Names

Pall Syringe Filter PharmAssure Syringe Filter PharmAssure Vent Filter Transducer Protector; 25 mm Vent Filter LaparoShield Plus Laparoscopic Smoke Filter LaparoShield Plus Laparoscopic Smoke Filtration System Gardian 25mm Syringe Filter Pall-Aquasafe Water Filter Ultipor 100 Breathing System Filter with Flex Tube Conserve Small Volume HME Filter Ultipor 100 Breathing System Filter with CO2 Monitoring Port Ultipor Breathing Circuit Filter Ultipor 100 Breathing System Filter Ultipor U55 Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger Freezing Bag Thermogenesis Freezing Bag Briostor Transfer/Freezing bag set Expandable Flex Tube 15 mm X 5" Anesthesia Breathing Circuit - Breathing Bag 2L Anesthesia Breathing Circuit - Adult Machine Kit 96 2Lbag NCO2 Patient Kit - Adult Mask Medium Patient Kit - Pediatric Mask Anesthesia Breathing Circuit - Adult Kit 40 Coax Anesthesia Breathing Circuit - Ped Machine Kit 96 Anesthesia Breathing Circuit - Adult Kit 60 Coax Pall Ultipor 25 Filter Patient Kit - Adult Mask Large Anesthesia Breathing Circuit - Expandable dual 40 CO2 Gas Sampling line Patient Kit - Adult Mask Extra (Ultra) large Anesthesia Breathing Circuit - Adult Machine Kit 96 2Lbag Elbow Anesthesia Breathing Circuit - Adult Kit 72 Nonexp Anesthesia Breathing Circuit - Adult Kit 72 Coax Anesthesia Breathing Circuit - Ped Kit 72 Coax Patient Kit - Adult Mask Small Anesthesia Breathing Circuit - Breathing Bag 3L Anesthesia Breathing Circuit - Adult Machine Kit 96 3Lbag Medtronic ATBAG600 Medtronic ATBAG1000 Medtronic ATBAG300 Thermogenesis Transfer/Freezing Bag Set Transfer/Freezing Bag Set Cell Wash/Infusion Bag Pro-Tec Pulmonary Function Filter Total Nutrient Admixture Filter TNA Total Nutrient Admixture Filter TNA1 Pall QPoint Water Filter Capsule Pall QPoint Disposable Water Filter Qpoint Docking Station Shower Qpoint Docking Station Tap SUPOR SUPOR AEF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2003-08-29
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2011-03-17
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2007-12-19
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2013-01-31
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2016-07-12
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	1999-02-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2021-11-22
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2012-02-27
OAO	Cord Blood Processing System And Storage Container	Hematology	Class 2	864.9900	2016-07-12
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	1999-02-18
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2012-02-27
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2012-02-27
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2012-02-27
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2010-05-14
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	1994-03-30
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2017-07-07
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	1994-03-30

Official Correspondent

No official correspondent registered.

US Agent Details

Lois Ostringer Business: Pall Medical Email: Lois_Ostringer@pall.com Phone: (516) 8019299

Related Public Records

Same Entity

Pall Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2647898	PALL LIFE SCIENCES PUERTO RICO, LLC	Fajardo, PR, US
3008412416	Pall International, Sarl	Fribourg, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680602. Last updated year: 2026. Please use registration number 9680602 when referencing this establishment in official correspondence.