The following data is part of a premarket notification filed by Conception Technology, Inc. with the FDA for Enhance-s Plus H.
| Device ID | K030116 |
| 510k Number | K030116 |
| Device Name: | ENHANCE-S PLUS H |
| Classification | Media, Reproductive |
| Applicant | CONCEPTION TECHNOLOGY, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland CONCEPTION TECHNOLOGY, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-13 |
| Decision Date | 2003-02-12 |