The following data is part of a premarket notification filed by Sage In-vitro Fertilization Inc. with the FDA for Vitrification Kit & Vitrification Warming Kit.
| Device ID | K073522 |
| 510k Number | K073522 |
| Device Name: | VITRIFICATION KIT & VITRIFICATION WARMING KIT |
| Classification | Media, Reproductive |
| Applicant | SAGE IN-VITRO FERTILIZATION INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland SAGE IN-VITRO FERTILIZATION INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-12-14 |
| Decision Date | 2008-10-10 |
| Summary: | summary |