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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K954589
Device Name CLARK TUT IMAGE PROCESSING SYSTEM
Applicant
Clark Research and Development, Inc.
Number 13 Park Ln.
Folsom,  LA  70437
Applicant Contact MICHAEL S PEARL
Correspondent
Clark Research and Development, Inc.
Number 13 Park Ln.
Folsom,  LA  70437
Correspondent Contact MICHAEL S PEARL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/03/1995
Decision Date 01/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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