The following data is part of a premarket notification filed by Genx Intl., Inc. with the FDA for Global Blastocyst Vitrification Kit & Vitrification Thawing Kit - Based On S3.
| Device ID | K092963 |
| 510k Number | K092963 |
| Device Name: | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 |
| 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 | 2009-09-25 |
| Decision Date | 2011-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965020914 | K092963 | 000 |