K904316 is an FDA 510(k) clearance for the NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT. 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 October 11, 1990, 20 days after receiving the submission on September 21, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3800.
| 510(k) Number | K904316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 1990 |
| Decision Date | October 11, 1990 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KCZ — Prosthesis, Breast, External, Used With Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.3800 |