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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 K912956
Device Name ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT
Original Applicant
ATRIUM MEDICAL CORP.
17 clinton dr.
hollis,  NH  03049
Original Contact ted karwoski
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/08/1991
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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