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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, Stationary
510(k) Number K855161
Device Name UPRIGHT BUCKY STAND/MOUNT
Applicant
X-Ray Systems
33061 Groesbeck Hwy.
Fraser,  MI  48026
Applicant Contact RICHARD DRUMB
Correspondent
X-Ray Systems
33061 Groesbeck Hwy.
Fraser,  MI  48026
Correspondent Contact RICHARD DRUMB
Regulation Number892.1680
Classification Product Code
KPR  
Date Received12/26/1985
Decision Date 02/12/1986
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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