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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K130131
FOIA Releasable 510(k) K130131
Device Name EDRAIN CHEST DRAINAGE SYSTEM
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR
HUDSON,  NH  03051
Applicant Contact CHRISTINA CALDERWOOD
Correspondent
ATRIUM MEDICAL CORP.
5 WENTWORTH DR
HUDSON,  NH  03051
Correspondent Contact CHRISTINA CALDERWOOD
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
KDQ  
Date Received01/18/2013
Decision Date 02/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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