K171639 is an FDA 510(k) clearance for the Trojan Supra Lubricated Polyurethane Male Condom. This device is classified as a Condom, Synthetic (Class II - Special Controls, product code MOL).
Submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on August 1, 2017, 60 days after receiving the submission on June 2, 2017.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K171639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2017 |
| Decision Date | August 01, 2017 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MOL — Condom, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |