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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 K853682
Device Name MOUNT TUBE RADIOGRAPHIC
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 Number892.1770
Classification Product Code
IYB  
Date Received09/04/1985
Decision Date 09/19/1985
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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