K080040 is an FDA 510(k) clearance for the ORTHO ALL-FLEX DIAPHRAGM, a Diaphragm, Contraceptive (and Accessories) (Class II — Special Controls, product code HDW), submitted by Johnson & Johnson Produtos Profissionais Ltda. (Claremont, US). The FDA issued a Cleared decision on August 25, 2008, 231 days after receiving the submission on January 7, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5350.
| 510(k) Number | K080040 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 07, 2008 |
| Decision Date | August 25, 2008 |
| Days to Decision | 231 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 |