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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, autotransfusion
510(k) Number K912609
Device Name MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950
Original Applicant
ATRIUM MEDICAL CORP.
17 clinton dr.
hollis,  NH  03049
Original Contact ted karwoski
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/12/1991
Decision Date 11/29/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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