The following data is part of a premarket notification filed by Ferti Pro N.v. with the FDA for Vitrifreeze Medium; Vitrithaw Medium.
| Device ID | K070135 |
| 510k Number | K070135 |
| Device Name: | VITRIFREEZE MEDIUM; VITRITHAW MEDIUM |
| Classification | Media, Reproductive |
| Applicant | FERTI PRO N.V. 3722 AVENUE SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland FERTI PRO N.V. 3722 AVENUE SAUSALITO Irvine, CA 92606 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05411967002139 | K070135 | 000 |
| 05411967002122 | K070135 | 000 |
| 05411967002115 | K070135 | 000 |
| 05411967002108 | K070135 | 000 |
| 05411967002054 | K070135 | 000 |
| 05411967002047 | K070135 | 000 |
| 05411967002030 | K070135 | 000 |
| 05411967001439 | K070135 | 000 |
| 05411967001415 | K070135 | 000 |