FPY · Class I · 21 CFR 880.5180

FDA Product Code FPY: Sheet, Burn

Leading manufacturers include American Medical Disposable, Inc., Acme United Corp. and American Convertors Div., American Pharmaseal.

17
Total
17
Cleared
123d
Avg days
1976
Since

FDA 510(k) Cleared Sheet, Burn Devices (Product Code FPY)

17 devices
1–17 of 17
Cleared Jun 09, 1987
LYOSHEET SURGICAL SHEET FOR BURNS
K871740
Acme United Corp.
General & Plastic Surgery · 35d
Cleared Aug 30, 1985
KENDALL CURITY BURN PAD
K853145
The Kendal Co.
General & Plastic Surgery · 32d
Cleared May 13, 1982
ABSORB FURN SHEET
K820994
American Convertors Div., American Pharmaseal
General & Plastic Surgery · 35d
Cleared Dec 20, 1979
TEMPORARY BURN SHEET WITH PERFORATED
K792432
American Medical Disposable, Inc.
General & Plastic Surgery · 22d
Cleared Dec 20, 1979
TEMPORARY BURN SHEET WITH PERFORATED
K792433
American Medical Disposable, Inc.
General & Plastic Surgery · 22d

About Product Code FPY - Regulatory Context