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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 K932848
Device Name SIMULIX-MC CT EXTENSION
Applicant
Oldelft Corp. of America
2735 Dorr Ave.
Fairfax,  VA  22031
Applicant Contact SHARON BOWLING
Correspondent
Oldelft Corp. of America
2735 Dorr Ave.
Fairfax,  VA  22031
Correspondent Contact SHARON BOWLING
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/10/1993
Decision Date 03/22/1994
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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