The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Htf Plus With Hepes (htf With Non-essential Amino Acids).
Device ID | K022352 |
510k Number | K022352 |
Device Name: | HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) |
Classification | Media, Reproductive |
Applicant | INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06443 |
Contact | Michael D Cecchi |
Correspondent | Michael D Cecchi INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06443 |
Product Code | MQL |
CFR Regulation Number | 884.6180 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-19 |
Decision Date | 2002-08-28 |