K082939 is an FDA 510(k) clearance for the COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Cook Urological, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 3, 2009, 336 days after receiving the submission on October 2, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K082939 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 02, 2008 |
| Decision Date | September 03, 2009 |
| Days to Decision | 336 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNA — Instrument, Manual, Specialized Obstetric-gynecologic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |