HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)

Media, Reproductive

INTL., INC.

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).

Pre-market Notification Details

Device IDK022352
510k NumberK022352
Device Name:HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
ClassificationMedia, Reproductive
Applicant INTL., INC. 393 SOUNDVIEW RD. Guilford,  CT  06443
ContactMichael D Cecchi
CorrespondentMichael D Cecchi
INTL., INC. 393 SOUNDVIEW RD. Guilford,  CT  06443
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-19
Decision Date2002-08-28

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