K070135 is an FDA 510(k) clearance for the VITRIFREEZE MEDIUM; VITRITHAW MEDIUM, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Fertipro NV (Irvine, US). The FDA issued a Cleared decision on August 16, 2007, 212 days after receiving the submission on January 16, 2007. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K070135 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2007 |
| Decision Date | August 16, 2007 |
| Days to Decision | 212 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 |