K921535 is an FDA 510(k) clearance for the SUOENA AFFINITY (TM) 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 May 11, 1992, 41 days after receiving the submission on March 31, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3800.
| 510(k) Number | K921535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1992 |
| Decision Date | May 11, 1992 |
| Days to Decision | 41 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 |