K915382 is an FDA 510(k) clearance for the AMOENA AFFINITY MODEL #802. This device is classified as a Prosthesis, Breast, External, Used With Adhesive (Class I - General Controls, product code KCZ).
Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on January 14, 1992, 46 days after receiving the submission on November 29, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3800.
| 510(k) Number | K915382 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 1991 |
| Decision Date | January 14, 1992 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KCZ — Prosthesis, Breast, External, Used With Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.3800 |