MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955

Apparatus, Autotransfusion

ATRIUM MEDICAL CORP.

The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Mini-op Ats Blood Recovery Bag, Model 2955.

Pre-market Notification Details

Device IDK912610
510k NumberK912610
Device Name:MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955
ClassificationApparatus, Autotransfusion
Applicant ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis,  NH  03049
ContactTed Karwoski
CorrespondentTed Karwoski
ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis,  NH  03049
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-12
Decision Date1991-11-29

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