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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 K040256
Device Name PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005
Applicant
Bio-Detek, Inc.
525 Narragansett Park Dr.
Pawtucket,  RI  02861 -4323
Applicant Contact ROBERT MORSE
Correspondent
Bio-Detek, Inc.
525 Narragansett Park Dr.
Pawtucket,  RI  02861 -4323
Correspondent Contact ROBERT MORSE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/04/2004
Decision Date 04/09/2004
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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