GBI · Class I · 21 CFR 878.3800

FDA Product Code GBI: Material, External Aesthetic Restoration, Used With Adhesive

Leading manufacturers include Coloplast Corp., Beiersdorf, Inc. and Sil-Med Corp..

17
Total
17
Cleared
61d
Avg days
1977
Since

FDA 510(k) Cleared Material, External Aesthetic Restoration, Used With Adhesive Devices (Product Code GBI)

17 devices
1–17 of 17
Cleared Jan 08, 1987
AMOENA BREAST FORMS
K864785
Coloplast Corp.
General & Plastic Surgery · 31d
Cleared Jan 08, 1987
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
K864786
Coloplast Corp.
General & Plastic Surgery · 31d
Cleared Sep 30, 1985
AMOENA BREAST FORMS
K853822
Coloplast Corp.
General & Plastic Surgery · 17d
Cleared Aug 17, 1984
SILIMED BREAST FORM
K842765
Sil-Med Corp.
General & Plastic Surgery · 32d
Cleared Jul 17, 1984
CONFORMA
K841559
Beiersdorf, Inc.
General & Plastic Surgery · 92d

About Product Code GBI - Regulatory Context