K053494 is an FDA 510(k) clearance for the OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Fertipro NV (Irvine, US). The FDA issued a Cleared decision on March 23, 2006, 98 days after receiving the submission on December 15, 2005. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K053494 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 15, 2005 |
| Decision Date | March 23, 2006 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6180 |