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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 (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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