Product code GBI
- Device name
- Material, External Aesthetic Restoration, Used With Adhesive
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.3800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K880329 | FACTOR II PROSTHETIC SILICONE ELASTOMER | Factor, Ii, Inc. | 1988-06-01 |
| K874279 | AHH NATURAL BREAST FORM | Pacific Prosthetics, Inc. | 1987-10-29 |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Roseburg SA | 1987-07-21 |
| K864786 | PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT | Coloplast Corp. | 1987-01-08 |
| K864785 | AMOENA BREAST FORMS | Coloplast Corp. | 1987-01-08 |
| K853822 | AMOENA BREAST FORMS | Coloplast Corp. | 1985-09-30 |
| K851668 | PROSTHESIS OR SURGICAL PADS | Virginia Hall, Inc. | 1985-06-04 |
| K842765 | SILIMED BREAST FORM | Sil-Med Corp. | 1984-08-17 |
| K841559 | CONFORMA | Beiersdorf, Inc. | 1984-07-17 |
| K841171 | TRILICON BREASE PROSTHESIS DIFFERENT | Baurs Krey Assoc., Inc. | 1984-04-25 |
| K832151 | PDM SILOXANE PROSTHETIC ORBIT | Delaware Prosthetics, Inc. | 1983-12-19 |
| K832153 | PDM SILOXANE PROSTHETIC NOSE | Delaware Prosthetics, Inc. | 1983-12-09 |
| K832152 | PDM SILOXANE PROSTHETIC EAR | Delaware Prosthetics, Inc. | 1983-12-09 |
| K831831 | TRULIFE SILICONE BREAST FORM | Medeering, Ltd. | 1983-06-30 |
| K813416 | EXTERNAL BREAST PROSTHESIS | Surgical Appliance Industries, Inc. | 1982-01-18 |
| K792372 | IPOS BREAST PROSTHESIS | Ipos KG | 1979-12-19 |
| K770359 | IMPLANTING OF POLYACRYLIC FIBERS | Allan V. Marse | 1977-04-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060483013022 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483016221 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483016214 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483016207 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483016191 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483016184 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483016177 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483016108 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483013138 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483013114 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483013107 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483013084 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483013077 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483013053 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483013046 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012087 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483013015 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012995 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012704 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012698 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012476 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012452 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012162 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012155 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012148 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012131 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012124 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012117 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012100 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |
| 05060483012094 | Prosthetic Silicone Materials | TECHNOVENT LIMITED | 2024-07-22 |