The following data is part of a premarket notification filed by Genx Intl., Inc. with the FDA for Global Dmso Blastocyst Vitrification Kit And Warming Kit.
| Device ID | K092667 |
| 510k Number | K092667 |
| Device Name: | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT |
| Classification | Media, Reproductive |
| Applicant | GENX INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06437 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi GENX INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06437 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-08-31 |
| Decision Date | 2010-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965020907 | K092667 | 000 |
| 00815965020891 | K092667 | 000 |