K813416 is an FDA 510(k) clearance for the EXTERNAL BREAST PROSTHESIS. This device is classified as a Material, External Aesthetic Restoration, Used With Adhesive (Class I - General Controls, product code GBI).
Submitted by Surgical Appliance Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1982, 42 days after receiving the submission on December 7, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3800.
| 510(k) Number | K813416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1981 |
| Decision Date | January 18, 1982 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GBI — Material, External Aesthetic Restoration, Used With Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.3800 |