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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Tilting
510(k) Number K843926
Device Name PRESTILIX 1690
Applicant
Cgr Medical Corp.
10150 Old Columbia Rd.
Columbia,  MD  21046
Applicant Contact DENNIS E UPRIGHT
Correspondent
Cgr Medical Corp.
10150 Old Columbia Rd.
Columbia,  MD  21046
Correspondent Contact DENNIS E UPRIGHT
Regulation Number892.1980
Classification Product Code
IXR  
Date Received10/27/1984
Decision Date 12/17/1984
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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