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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion
510(k) Number K090736
Device Name POWER INFUSER, MODEL M100B-3A
Applicant
ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD,  MA 
Applicant Contact EILEEN M BOYLE
Correspondent
ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD,  MA 
Correspondent Contact EILEEN M BOYLE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/19/2009
Decision Date 05/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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