K213547 is an FDA 510(k) clearance for the SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Ttk Healthcare Limited (Puducherry, IN). The FDA issued a Cleared decision on December 23, 2021, 45 days after receiving the submission on November 8, 2021.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K213547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2021 |
| Decision Date | December 23, 2021 |
| Days to Decision | 45 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 |