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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
Recalls CDRH Recalls
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