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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K964460
Device Name THE ROBOLITE
Applicant
Shai Syg Motion and Innovations, Ltd.
Pob 6718
Efrat,  IL 90435
Applicant Contact ELI ORBACH
Correspondent
Shai Syg Motion and Innovations, Ltd.
Pob 6718
Efrat,  IL 90435
Correspondent Contact ELI ORBACH
Regulation Number862.2100
Classification Product Code
JQP  
Date Received11/07/1996
Decision Date 01/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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