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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 K100565
Device Name DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
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 Received03/01/2010
Decision Date 11/16/2010
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
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