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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 K852952
Device Name TRAUMA STAND
Applicant
Xre Corp.
300 Foster St.
Littleton,  MA  01460
Applicant Contact DONNA GLENCROSS
Correspondent
Xre Corp.
300 Foster St.
Littleton,  MA  01460
Correspondent Contact DONNA GLENCROSS
Regulation Number892.1770
Classification Product Code
IYB  
Date Received07/11/1985
Decision Date 09/26/1985
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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