GAMBRO HEMOFREEZE-BAG

Container, Empty, For Collection & Processing Of Blood & Blood Components

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Hemofreeze-bag.

Pre-market Notification Details

Device IDK801082
510k NumberK801082
Device Name:GAMBRO HEMOFREEZE-BAG
ClassificationContainer, Empty, For Collection & Processing Of Blood & Blood Components
Applicant GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKSR  
CFR Regulation Number864.9100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-07
Decision Date1980-10-31

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