K200672 is an FDA 510(k) clearance for the Durex Penck Standard, Durex Penck XL, a Condom (Class II — Special Controls, product code HIS), submitted by Rb Health (Us), LLC (Parsippany, US). The FDA issued a Cleared decision on November 6, 2020, 238 days after receiving the submission on March 13, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K200672 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 13, 2020 |
| Decision Date | November 06, 2020 |
| Days to Decision | 238 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 |