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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 Rd.
Chelsmford,  MA  01824
Applicant Contact PAUL DIAS
Correspondent
Zoll Medical Corporation, World Wide Headquarters
269 Mill Rd.
Chelsmford,  MA  01824
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
Predetermined Change
Control Plan Authorized		 No
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