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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 K885322
Device Name 3D/DENTAL
Applicant
Columbia Scientific, Inc.
8940-K Old Annapolis Rd.
Columbia,  MD  21045
Applicant Contact CHARLES STOCKHAM
Correspondent
Columbia Scientific, Inc.
8940-K Old Annapolis Rd.
Columbia,  MD  21045
Correspondent Contact CHARLES STOCKHAM
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/28/1988
Decision Date 02/09/1989
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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