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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aid, Cardiopulmonary Resuscitation
510(k) Number K071321
Device Name POCKETCPR
Applicant
Bio-Detek, Inc.
525 Narragansett Park Dr.
Pawtucket,  RI  02861
Applicant Contact MARK TOTMAN
Correspondent
Bio-Detek, Inc.
525 Narragansett Park Dr.
Pawtucket,  RI  02861
Correspondent Contact MARK TOTMAN
Regulation Number870.5210
Classification Product Code
LIX  
Date Received05/10/2007
Decision Date 09/12/2007
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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