K140305 is an FDA 510(k) clearance for the CAYA CONTOURED DIAPHRAGM, a Diaphragm, Contraceptive (and Accessories) (Class II — Special Controls, product code HDW), submitted by Kessel Medintim GmbH (Frankfurt, DE). The FDA issued a Cleared decision on August 26, 2014, 200 days after receiving the submission on February 7, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5350.
| 510(k) Number | K140305 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 07, 2014 |
| Decision Date | August 26, 2014 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDW — Diaphragm, Contraceptive (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5350 |