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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 K011388
Device Name ZOLL PAD
Applicant
Zoll Medical Corp
32 Second Ave.
Burlington,  MA  01803
Applicant Contact PAUL DIAS
Correspondent
Zoll Medical Corp
32 Second Ave.
Burlington,  MA  01803
Correspondent Contact PAUL DIAS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received05/07/2001
Decision Date 03/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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