K953640 is an FDA 510(k) clearance for the DUNA II PENILE PROSTHESIS. This device is classified as a Prosthesis, Penile (Class II - Special Controls, product code FAE).
Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on October 27, 1995, 84 days after receiving the submission on August 4, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.3630.
| 510(k) Number | K953640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1995 |
| Decision Date | October 27, 1995 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAE — Prosthesis, Penile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.3630 |