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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 K984582
Device Name ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX
Applicant
BIO-DETEK, INC.
525 NARRAGANSETT PARK DR.
PAWTUCKET,  RI  02861 -4323
Applicant Contact MICHAEL R DUPELLE
Correspondent
BIO-DETEK, INC.
525 NARRAGANSETT PARK DR.
PAWTUCKET,  RI  02861 -4323
Correspondent Contact MICHAEL R DUPELLE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received12/23/1998
Decision Date 03/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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