STAGO FACTOR VII-DEFICIENT PLASMA

Plasma, Coagulation Factor Deficient

AMERICAN BIOPRODUCTS CO.

The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Stago Factor Vii-deficient Plasma.

Pre-market Notification Details

Device IDK933440
510k NumberK933440
Device Name:STAGO FACTOR VII-DEFICIENT PLASMA
ClassificationPlasma, Coagulation Factor Deficient
Applicant AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany,  NJ  07054
ContactAndrew Loc B Le
CorrespondentAndrew Loc B Le
AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany,  NJ  07054
Product CodeGJT  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-14
Decision Date1993-10-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
13607450007432 K933440 000

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