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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Electrical
510(k) Number K853535
Device Name TRAUMA TABLE
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 Number878.4960
Classification Product Code
GDC  
Date Received08/23/1985
Decision Date 09/11/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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