K063223 is an FDA 510(k) clearance for the MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS. This device is classified as a Diaphragm, Contraceptive (and Accessories) (Class II - Special Controls, product code HDW).
Submitted by CooperSurgical, Inc. (Shelton, US). The FDA issued a Cleared decision on January 23, 2008, 456 days after receiving the submission on October 24, 2006.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5350.
| 510(k) Number | K063223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2006 |
| Decision Date | January 23, 2008 |
| Days to Decision | 456 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 |