The following data is part of a premarket notification filed by Ferti Pro N.v. with the FDA for Oil For Tissue Culture, Gradient System And Spermfreeze.
| Device ID | K053494 |
| 510k Number | K053494 |
| Device Name: | OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE |
| 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 | Yes |
| Date Received | 2005-12-15 |
| Decision Date | 2006-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859268006237 | K053494 | 000 |
| 00858604006177 | K053494 | 000 |
| 00858604006184 | K053494 | 000 |
| 00858604006191 | K053494 | 000 |
| 00858604006207 | K053494 | 000 |
| 00858604006214 | K053494 | 000 |
| 00859268006152 | K053494 | 000 |
| 00859268006169 | K053494 | 000 |
| 00859268006176 | K053494 | 000 |
| 00859268006183 | K053494 | 000 |
| 00859268006190 | K053494 | 000 |
| 00859268006206 | K053494 | 000 |
| 00859268006213 | K053494 | 000 |
| 00859268006220 | K053494 | 000 |
| 00858604006146 | K053494 | 000 |