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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 K904794
Device Name IN-LINE ATS BLOOD RECOVERY BAG
Applicant
ATRIUM MEDICAL CORP.
17 CLINTON DR.
HOLLIS,  NH  03049
Applicant Contact TED KARWOSKI
Correspondent
ATRIUM MEDICAL CORP.
17 CLINTON DR.
HOLLIS,  NH  03049
Correspondent Contact TED KARWOSKI
Regulation Number868.5830
Classification Product Code
CAC  
Date Received10/23/1990
Decision Date 01/08/1991
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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