Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008254127

FEI Number

3008254127

Entity Name

THE O R COMPANY PTY LTD

City/State/Country

Cheltenham Victoria, AU

Establishment Address

4/47 Wangara Road, Cheltenham Victoria 3192, AU

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Foreign Private Label Distributor

Owner / Operator

The O R Company Pty Ltd (Owner Number: 10031641)

Owner / Operator Contact Address

4/47 Wangara Road, Cheltenham, AU-VIC 3192, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Occluder Balloon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2013-05-21
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2019-02-11
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2015-04-15
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2013-06-03
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1640	2010-02-22
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2022-01-17
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2022-04-06
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-04-16
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2013-05-21

Official Correspondent

Justin Abraham

US Agent Details

Chris Smith Business: ASPEN SURGICAL PRODUCTS, INC. Email: chris.smith@aspensurgical.com Phone: (615) 9645392

Related Public Records

Same Entity

The O R Company Pty Ltd

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
K981334	Richard Wolf Medical Instruments Corp.	LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)	1998-09-10

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2953359	Sterigenics U.S. LLC	Hayward, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008254127. Last updated year: 2026. Please use registration number 3008254127 when referencing this establishment in official correspondence.