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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
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