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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 K883663
Device Name ATS BLOOD RECOVERY BAG
Original Applicant
ATRIUM MEDICAL CORP.
17 clinton dr.
hollis,  NH  03049
Original Contact ted karwoski
Regulation Number868.5830
Classification Product Code
CAC  
Date Received08/26/1988
Decision Date 09/30/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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