K000748 is an FDA 510(k) clearance for the TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT. 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 6, 2000, 29 days after receiving the submission on March 8, 2000.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K000748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2000 |
| Decision Date | April 06, 2000 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIS — Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |