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 |