GBIClass I
Material, External Aesthetic Restoration, Used With Adhesive
General, Plastic Surgery · 21 CFR 878.3800
MDR events0All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances17All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
17 clearances for this product code
- Factor, Ii, Inc.Jun 1, 1988
K880329 · FACTOR II PROSTHETIC SILICONE ELASTOMER
- Pacific Prosthetics, Inc.Oct 29, 1987
K874279 · AHH NATURAL BREAST FORM
- Roseburg SAJul 21, 1987
K872714 · S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
- Coloplast Corp.Jan 8, 1987
K864785 · AMOENA BREAST FORMS
- Coloplast Corp.Jan 8, 1987
K864786 · PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
- Coloplast Corp.Sep 30, 1985
K853822 · AMOENA BREAST FORMS
- Virginia Hall, Inc.Jun 4, 1985
K851668 · PROSTHESIS OR SURGICAL PADS
- Sil-Med Corp.Aug 17, 1984
K842765 · SILIMED BREAST FORM