Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1526809

FEI Number

1526809

Entity Name

Western Enterprises, Inc.

City/State/Country

Westlake, OH, US

Establishment Address

875 Bassett Rd, Westlake, OH 44145, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Western Enterprises (Owner Number: 10078620)

Owner / Operator Contact Address

875 Bassett Road, Westlake, OH 44145, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Western/Scott Fetzer Roberts Oxygen ROC-xxxx Linde Opti Western/Scott Fetzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2020-10-29
CAM	Yoke Assembly, Medical Gas	Anesthesiology	Class 1	868.6885	2020-10-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Western Enterprises

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
K780365	Spica, Inc.	OXYGEN/NITROUS OXIDE OUTLET	1978-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

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1062191	Inovo Inc.	Lehigh Acres, FL, US
1924066	Allied Medical LLC	Earth City, MO, US
3020460367	BOUND TREE MEDICAL, LLC	Grand Prairie, TX, US
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1526809. Last updated year: 2026. Please use registration number 1526809 when referencing this establishment in official correspondence.