K885323 is an FDA 510(k) clearance for the DACOMED EXTERNAL MALE CONTINENCE DEVICE. This device is classified as a Clamp, Penile (Class I - General Controls, product code FHA).
Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on February 8, 1989, 42 days after receiving the submission on December 28, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5160.
| 510(k) Number | K885323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1988 |
| Decision Date | February 08, 1989 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FHA — Clamp, Penile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5160 |