Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1220351

FEI Number

1220351

Entity Name

Dielectrics, Inc.

City/State/Country

CHICOPEE, MA, US

Establishment Address

300 BURNETT RD., CHICOPEE, MA 01020, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dielectrics, Inc. (Owner Number: 1220351)

Owner / Operator Contact Address

300 Burnett Road, --, Chicopee, MA 01020, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SofCare Chair Cushion PneumoLiner Altrix Wrap Safeguard Pressure Assisted Dressing (12cm) PneumoLiner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2016-03-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-08-08
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2016-03-10
PMU	Containment System, Laparoscopic Power Morcellation, With Instrument Port	Obstetrics/Gynecology	Class 2	884.4050	2016-10-27
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2018-08-21
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2016-05-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-12-16
OTJ	Laparoscopic Single Port Access Device	Gastroenterology, Urology	Class 2	876.1500	2013-12-16
PMU	Containment System, Laparoscopic Power Morcellation, With Instrument Port	Obstetrics/Gynecology	Class 2	884.4050	2020-05-21
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2018-12-11

Official Correspondent

Cheryl Cormier

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Dielectrics, Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220351. Last updated year: 2026. Please use registration number 1220351 when referencing this establishment in official correspondence.