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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K974679
Device Name THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
Applicant
Medcon , Ltd.
Pob 6718
C/O Intl Regulatory Consultant
Efrat,  IL 90435
Applicant Contact ELI M ORBACH
Correspondent
Medcon , Ltd.
Pob 6718
C/O Intl Regulatory Consultant
Efrat,  IL 90435
Correspondent Contact ELI M ORBACH
Regulation Number892.1600
Classification Product Code
IZI  
Date Received12/15/1997
Decision Date 03/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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