K890863 is an FDA 510(k) clearance for the TROJAN FOR WOMEN. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on April 4, 1989, 42 days after receiving the submission on February 21, 1989.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K890863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1989 |
| Decision Date | April 04, 1989 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HIS — Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |