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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 K861852
Device Name CSI/MPR OR CSI/MPR PLUS
Applicant
Columbia Scientific, Inc.
8940-K Old Annapolis Rd.
Columbia,  MD  21045
Applicant Contact CHARLES D STOCKHAM
Correspondent
Columbia Scientific, Inc.
8940-K Old Annapolis Rd.
Columbia,  MD  21045
Correspondent Contact CHARLES D STOCKHAM
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/14/1986
Decision Date 10/08/1986
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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