The following data is part of a premarket notification filed by Conception Technologies with the FDA for Enhance Htf Medium With Hepes.
| Device ID | K023655 |
| 510k Number | K023655 |
| Device Name: | ENHANCE HTF MEDIUM WITH HEPES |
| Classification | Media, Reproductive |
| Applicant | CONCEPTION TECHNOLOGIES 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland CONCEPTION TECHNOLOGIES 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-30 |
| Decision Date | 2002-12-13 |