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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, Mammographic
510(k) Number K961849
Device Name THE ROBOGUIDE
Applicant
Shai Syg Motion and Innovations, Ltd.
Pob 6718
Efrat,  IL 90435
Applicant Contact ELI M ORBACH
Correspondent
Shai Syg Motion and Innovations, Ltd.
Pob 6718
Efrat,  IL 90435
Correspondent Contact ELI M ORBACH
Regulation Number892.1710
Classification Product Code
IZH  
Date Received05/13/1996
Decision Date 08/21/1996
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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