The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Htf Medium And Modified Htf Medium-hepes.
Device ID | K871577 |
510k Number | K871577 |
Device Name: | HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES |
Classification | Cap, Cervical |
Applicant | IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
Contact | Paul Weathersbee,phd |
Correspondent | Paul Weathersbee,phd IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
Product Code | HDR |
CFR Regulation Number | 884.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-23 |
Decision Date | 1987-07-15 |