K150950 is an FDA 510(k) clearance for the FreezeKit Cleave , ThawKit Cleave. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Vitrolife Sweden AB (Englewood, US). The FDA issued a Cleared decision on December 21, 2015, 257 days after receiving the submission on April 8, 2015.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K150950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2015 |
| Decision Date | December 21, 2015 |
| Days to Decision | 257 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 |