K180104 is an FDA 510(k) clearance for the Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on March 14, 2018, 57 days after receiving the submission on January 16, 2018.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K180104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2018 |
| Decision Date | March 14, 2018 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIS — Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |