FDA Product Code
FDA Product Code GBI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3800
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K880329 | FACTOR II PROSTHETIC SILICONE ELASTOMER | Factor, Ii, Inc. | 1988-06-01 | Traditional | PDF ↗ |
| K874279 | AHH NATURAL BREAST FORM | Pacific Prosthetics, Inc. | 1987-10-29 | Traditional | PDF ↗ |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Roseburg SA | 1987-07-21 | Traditional | PDF ↗ |
| K864785 | AMOENA BREAST FORMS | Coloplast Corp. | 1987-01-08 | Traditional | PDF ↗ |
| K864786 | PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT | Coloplast Corp. | 1987-01-08 | Traditional | PDF ↗ |
| K853822 | AMOENA BREAST FORMS | Coloplast Corp. | 1985-09-30 | Traditional | PDF ↗ |
| K851668 | PROSTHESIS OR SURGICAL PADS | Virginia Hall, Inc. | 1985-06-04 | Traditional | PDF ↗ |
| K842765 | SILIMED BREAST FORM | Sil-Med Corp. | 1984-08-17 | Traditional | PDF ↗ |
| K841559 | CONFORMA | Beiersdorf, Inc. | 1984-07-17 | Traditional | PDF ↗ |
| K841171 | TRILICON BREASE PROSTHESIS DIFFERENT | Baurs Krey Assoc., Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K832151 | PDM SILOXANE PROSTHETIC ORBIT | Delaware Prosthetics, Inc. | 1983-12-19 | Traditional | PDF ↗ |
| K832152 | PDM SILOXANE PROSTHETIC EAR | Delaware Prosthetics, Inc. | 1983-12-09 | Traditional | PDF ↗ |
| K832153 | PDM SILOXANE PROSTHETIC NOSE | Delaware Prosthetics, Inc. | 1983-12-09 | Traditional | PDF ↗ |
| K831831 | TRULIFE SILICONE BREAST FORM | Medeering, Ltd. | 1983-06-30 | Traditional | PDF ↗ |
| K813416 | EXTERNAL BREAST PROSTHESIS | Surgical Appliance Industries, Inc. | 1982-01-18 | Traditional | PDF ↗ |
| K792372 | IPOS BREAST PROSTHESIS | Ipos KG | 1979-12-19 | Traditional | PDF ↗ |
| K770359 | IMPLANTING OF POLYACRYLIC FIBERS | Allan V. Marse | 1977-04-08 | Traditional | PDF ↗ |
Product code GBI · Class I · General, Plastic Surgery. Data: openFDA.