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 |