The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Global Fertilization, Embryo Culture And Transfer Media.
| Device ID | K053552 |
| 510k Number | K053552 |
| Device Name: | GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA |
| Classification | Media, Reproductive |
| Applicant | INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06437 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi 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 | No |
| Date Received | 2005-12-20 |
| Decision Date | 2006-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965020075 | K053552 | 000 |
| 00815965020068 | K053552 | 000 |
| 00815965020051 | K053552 | 000 |
| 00815965020044 | K053552 | 000 |
| 00815965020037 | K053552 | 000 |
| 00815965020020 | K053552 | 000 |
| 00815965020013 | K053552 | 000 |
| 00815965020006 | K053552 | 000 |