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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, Stationary Top
510(k) Number K855052
Device Name TABLE RADIOGRAPHIC FIXED
Applicant
X-Ray Systems
33061 Groesbeck Hwy.
Fraser,  MI  48026
Applicant Contact DRUMB
Correspondent
X-Ray Systems
33061 Groesbeck Hwy.
Fraser,  MI  48026
Correspondent Contact DRUMB
Regulation Number892.1980
Classification Product Code
IXQ  
Date Received12/17/1985
Decision Date 02/06/1986
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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