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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Mount, X-Ray, Diagnostic
510(k) Number K880530
Device Name CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX
Applicant
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241 -3120
Applicant Contact RICHARD LUCAS
Correspondent
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241 -3120
Correspondent Contact RICHARD LUCAS
Regulation Number892.1770
Classification Product Code
IYB  
Date Received02/09/1988
Decision Date 03/03/1988
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
Recalls CDRH Recalls
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