Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1649245

FEI Number

3000214907

Entity Name

Garware Fulflex USA Inc. (previously AVCOR Health Care Products, Inc.)

City/State/Country

Fort Worth, TX, US

Establishment Address

7879 Will Rogers Blvd, Fort Worth, TX 76140, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Garware Fulflex USA Inc. (Owner Number: 9029354)

Owner / Operator Contact Address

7879 Will Rogers Blvd, --, Fort Worth, TX 76140, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BANDAGE, ELASTIC Pack, hot or cold, reusable Splint, extremity, non-inflatable, external, non-sterile BAG, ICE Dressing, compression FIBER, MEDICAL, ABSORBENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	1997-02-04
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2014-01-13
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2005-04-22
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2003-10-29
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2010-10-19
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2009-03-10

Official Correspondent

Elisa Maldonado-Holmertz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Garware Fulflex USA Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1649245. Last updated year: 2026. Please use registration number 1649245 when referencing this establishment in official correspondence.