The following data is part of a premarket notification filed by Conception Technologies with the FDA for Sperm Wash Medium With Gentamicin.
Device ID | K023717 |
510k Number | K023717 |
Device Name: | SPERM WASH MEDIUM WITH GENTAMICIN |
Classification | Media, Reproductive |
Applicant | CONCEPTION TECHNOLOGIES 6835 FLANDERS DR. SUITE 500 San Diego, CA 92121 |
Contact | John Corcoran |
Correspondent | John Corcoran CONCEPTION TECHNOLOGIES 6835 FLANDERS DR. SUITE 500 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 | 2002-11-05 |
Decision Date | 2002-12-13 |