CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)

Cap, Cervical

IRVINE SCIENTIFIC

The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Cat. #9972 Refrigeration Medium (test Yolk Buffer).

Pre-market Notification Details

Device IDK872203
510k NumberK872203
Device Name:CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)
ClassificationCap, Cervical
Applicant IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana,  CA  92705
ContactPaul S Weathersbee
CorrespondentPaul S Weathersbee
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 Received1987-06-08
Decision Date1987-08-14

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