The following data is part of a premarket notification filed by Invitrocare, Inc. with the FDA for Htf-hepes.
| Device ID | K000939 |
| 510k Number | K000939 |
| Device Name: | HTF-HEPES |
| Classification | Media, Reproductive |
| Applicant | INVITROCARE, INC. 11408 SORRENTO VALLEY RD. SUITE 202 San Diego, CA 92121 |
| Contact | Robert E Lovins |
| Correspondent | Robert E Lovins INVITROCARE, INC. 11408 SORRENTO VALLEY RD. SUITE 202 San Diego, CA 92121 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-23 |
| Decision Date | 2000-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859268006022 | K000939 | 000 |
| 00859268006015 | K000939 | 000 |
| 00859268006275 | K000939 | 000 |