HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES

Cap, Cervical

IRVINE SCIENTIFIC

The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Htf Medium And Modified Htf Medium-hepes.

Pre-market Notification Details

Device IDK871577
510k NumberK871577
Device Name:HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES
ClassificationCap, Cervical
Applicant IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana,  CA  92705
ContactPaul Weathersbee,phd
CorrespondentPaul Weathersbee,phd
IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana,  CA  92705
Product CodeHDR  
CFR Regulation Number884.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-23
Decision Date1987-07-15

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