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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K023356
Device Name KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
Applicant
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
Rehovot,  IL 76100
Applicant Contact ALEX GONOROVSKY
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
Rehovot,  IL 76100
Correspondent Contact ALEX GONOROVSKY
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received10/07/2002
Decision Date 01/16/2003
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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