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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, Tomography, Computed
510(k) Number K010813
Device Name SIMPLICT
Applicant
Neorad AS
103 Nolan Ln.
Chapel Hill,  NC  27516
Applicant Contact CHARLES H KYPER
Correspondent
Neorad AS
103 Nolan Ln.
Chapel Hill,  NC  27516
Correspondent Contact CHARLES H KYPER
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/19/2001
Decision Date 05/07/2001
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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