FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)

Cap, Cervical

IRVINE SCIENTIFIC

The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Freezing Medium (test Yolk Buffer W/glycerol).

Pre-market Notification Details

Device IDK872088
510k NumberK872088
Device Name:FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)
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 Received1987-06-01
Decision Date1987-08-14

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