The following data is part of a premarket notification filed by Invitrocare, Inc. with the FDA for Sperm Wash Medium, Cat# 2003/2005.
| Device ID | K000989 |
| 510k Number | K000989 |
| Device Name: | SPERM WASH MEDIUM, CAT# 2003/2005 |
| Classification | Media, Reproductive |
| Applicant | INVITROCARE, INC. 11408 SORRENTO VALLEY RD. SUITE 202 San Diego, CA 92121 |
| Contact | Rpbert E Lovins |
| Correspondent | Rpbert 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 | 2000-03-28 |
| Decision Date | 2000-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859268006084 | K000989 | 000 |
| 00859268006077 | K000989 | 000 |
| 00859268006060 | K000989 | 000 |
| 00859268006053 | K000989 | 000 |
| 00859268006039 | K000989 | 000 |
| 00859268006282 | K000989 | 000 |