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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dc-defibrillator, low-energy, (including paddles)
510(k) Number K102468
Device Name ZOLL PROPAQ MD
Applicant
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact PAUL DIAS
Correspondent
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
269 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact PAUL DIAS
Regulation Number870.5300
Classification Product Code
LDD  
Subsequent Product Codes
CCK   DQA   DRO   DRT   DSK  
DXN  
Date Received08/30/2010
Decision Date 09/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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