K202403 is an FDA 510(k) clearance for the SKORE (Colors & Flavors), SKORE (Colors). 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 April 15, 2021, 237 days after receiving the submission on August 21, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K202403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2020 |
| Decision Date | April 15, 2021 |
| Days to Decision | 237 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 |