GBI — Material, External Aesthetic Restoration, Used With Adhesive Class I
FDA product code GBI covers "Material, External Aesthetic Restoration, Used With Adhesive", a Class I medical device regulated under 21 CFR 878.3800. Submissions are reviewed by the General, Plastic Surgery panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GBI
- Device Class
- Class I
- Regulation Number
- 878.3800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K880329 | factor, ii | FACTOR II PROSTHETIC SILICONE ELASTOMER | June 1, 1988 |
| K874279 | pacific prosthetics | AHH NATURAL BREAST FORM | October 29, 1987 |
| K872714 | roseburg | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | July 21, 1987 |
| K864786 | coloplast | PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT | January 8, 1987 |
| K864785 | coloplast | AMOENA BREAST FORMS | January 8, 1987 |
| K853822 | coloplast | AMOENA BREAST FORMS | September 30, 1985 |
| K851668 | virginia hall | PROSTHESIS OR SURGICAL PADS | June 4, 1985 |
| K842765 | sil-med | SILIMED BREAST FORM | August 17, 1984 |
| K841559 | beiersdorf | CONFORMA | July 17, 1984 |
| K841171 | baurs krey assoc | TRILICON BREASE PROSTHESIS DIFFERENT | April 25, 1984 |
| K832151 | delaware prosthetics | PDM SILOXANE PROSTHETIC ORBIT | December 19, 1983 |
| K832153 | delaware prosthetics | PDM SILOXANE PROSTHETIC NOSE | December 9, 1983 |
| K832152 | delaware prosthetics | PDM SILOXANE PROSTHETIC EAR | December 9, 1983 |
| K831831 | medeering | TRULIFE SILICONE BREAST FORM | June 30, 1983 |
| K813416 | surgical appliance industries | EXTERNAL BREAST PROSTHESIS | January 18, 1982 |
| K792372 | ipos kg | IPOS BREAST PROSTHESIS | December 19, 1979 |
| K770359 | allan v. marse | IMPLANTING OF POLYACRYLIC FIBERS | April 8, 1977 |