FYE · Class I · 21 CFR 878.4040

FDA Product Code FYE: Dress, Surgical

Leading manufacturers include Barrier Concepts, Inc., Protect Corp. of Indiana, Inc. and Clinitech, Inc..

7
Total
7
Cleared
88d
Avg days
1989
Since

FDA 510(k) Cleared Dress, Surgical Devices (Product Code FYE)

7 devices
1–7 of 7
Cleared Apr 11, 1994
BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN
K932731
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 308d
Cleared Sep 19, 1991
SURGICAL GOWN
K912790
Unicor Federal Dept. of Justice
General & Plastic Surgery · 86d
Cleared May 15, 1991
PROTEKT GLOVES
K910920
Intermedics Orthopedics
General & Plastic Surgery · 71d
Cleared May 09, 1991
LIFELINER SURGICAL GLOVE
K910941
Depuy-Raynham
General & Plastic Surgery · 64d
Cleared Oct 13, 1989
STERILE SURGICAL GOWN
K895667
Clinitech, Inc.
General & Plastic Surgery · 23d
Cleared Sep 19, 1989
VARIOUS DISPOSABLE SURGICAL GARMENTS
K895235
Protect Corp. of Indiana, Inc.
General & Plastic Surgery · 43d
Cleared Aug 18, 1989
CLOTHINGUARD
K894760
Barrier Concepts, Inc.
General & Plastic Surgery · 22d

About Product Code FYE - Regulatory Context