K203727 is an FDA 510(k) clearance for the Harmony Latex Dam, Harmony Non-Latex Dam. This device is classified as a Barrier, Std, Oral Sex (Class II - Special Controls, product code MSC).
Submitted by Pamco Distributing, Inc. (Kitchener, CA). The FDA issued a Cleared decision on August 5, 2021, 227 days after receiving the submission on December 21, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K203727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2020 |
| Decision Date | August 05, 2021 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MSC - Barrier, Std, Oral Sex |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |