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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 K043140
Device Name EXPRESS AND OASIS CHEST DRAIN
Original Applicant
ATRIUM MEDICAL CORP.
5 wentworth dr.
hudson,  NH  03051
Original Contact joseph p de paolo
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/15/2004
Decision Date 12/08/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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