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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K971347
Device Name MEDISURF
Applicant
International Regulatory Consultants
Pob 6718
Efrat,  IL 90435
Applicant Contact ELI M ORBACH
Correspondent
International Regulatory Consultants
Pob 6718
Efrat,  IL 90435
Correspondent Contact ELI M ORBACH
Regulation Number892.2020
Classification Product Code
LMD  
Date Received04/10/1997
Decision Date 07/03/1997
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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