FRL · Class I · 21 CFR 880.5300

FDA Product Code FRL: Fiber, Medical, Absorbent

Leading manufacturers include American Hospital Supply Corp., Medical Engineering Corp. and Milliken Chemical.

19
Total
19
Cleared
82d
Avg days
1977
Since

FDA 510(k) Cleared Fiber, Medical, Absorbent Devices (Product Code FRL)

19 devices
1–19 of 19
Cleared May 24, 2013
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
K121898
Quick-Med Technologies, Inc.
General Hospital · 329d
Cleared Nov 04, 2011
INTERDRY SILVER
K110715
Milliken Healthcare Products, LLC
General Hospital · 234d
Cleared Dec 22, 2006
INTERDRY TEXTILE WITH SILVER
K061615
Milliken Chemical
General Hospital · 196d
Cleared Dec 02, 1993
CARAPACE STERILE COTTON BALLS
K931626
Carapace, Inc.
General Hospital · 244d
Cleared Oct 09, 1991
ICAN COTTON RAYON BALLS
K914081
Icn Pharmaceuticals, Inc.
General Hospital · 28d
Cleared Jul 27, 1981
TRACH CLEANING TRAY
K811990
Associated Medical Products Co.
General Hospital · 14d
Cleared Apr 15, 1981
UTENSIL & PROCEDURE TRAYS
K810242
American Hospital Supply Corp.
General Hospital · 77d
Cleared Feb 19, 1980
SURGITEK FOERSTER FACE LIFT BANDAGE
K800248
Medical Engineering Corp.
General Hospital · 13d
Cleared Feb 19, 1980
SURGITEK FOERSTER MAMMARY BANDAGE
K800249
Medical Engineering Corp.
General Hospital · 13d
Cleared Dec 20, 1979
SORBIES
K792295
American Hospital Supply Corp.
General Hospital · 37d
Cleared Dec 11, 1979
BREAST PAD
K792294
American Hospital Supply Corp.
General Hospital · 28d
Cleared Aug 03, 1979
DEXIDE DISPOSABLE PREP PAD
K791167
Dexide, Inc.
General Hospital · 39d
Cleared Oct 04, 1977
I.V. PREP & CARE KIT
K771551
Jelco Laboratories
General Hospital · 53d
Cleared May 23, 1977
COTTON BALL KIT
K770588
American Hospital Supply Corp.
General Hospital · 56d

About Product Code FRL - Regulatory Context