GBI — Material, External Aesthetic Restoration, Used With Adhesive Class I
FDA Device Classification
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 |