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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 K971714
Device Name NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO
Applicant
National Data Corp.
2 Ndc Plaza - Corporate Square
Atlanta,  GA  30329
Applicant Contact SANDRA BARNES
Correspondent
National Data Corp.
2 Ndc Plaza - Corporate Square
Atlanta,  GA  30329
Correspondent Contact SANDRA BARNES
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/09/1997
Decision Date 06/20/1997
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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