The following data is part of a premarket notification filed by Conception Technology, Inc. with the FDA for Enhance-s Plus.
Device ID | K991322 |
510k Number | K991322 |
Device Name: | ENHANCE-S PLUS |
Classification | Media, Reproductive |
Applicant | CONCEPTION TECHNOLOGY, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
Contact | Greg Holland |
Correspondent | Greg Holland CONCEPTION TECHNOLOGY, INC. 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 | 1999-04-19 |
Decision Date | 1999-07-26 |