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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
Applicant
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Applicant Contact JOSEPH P DE PAOLO
Correspondent
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Correspondent 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 Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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