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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K072812
Device Name PHILIPS HEARTSTART SMARTPADS III
Applicant
Philips Medical Systems
2301 Fifth Ave., Suite 200
Seattle,  WA  98121
Applicant Contact LARRY WALKER
Correspondent
Philips Medical Systems
2301 Fifth Ave., Suite 200
Seattle,  WA  98121
Correspondent Contact LARRY WALKER
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
MLN  
Date Received10/01/2007
Decision Date 02/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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