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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, Ac-Powered
510(k) Number K941150
Device Name MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES
Applicant
MDT TECHNOLOGY FOR LIFE
1777 EAST HENRIETTA RD.
P.O. BOX 23077
ROCHESTER,  NY  14692 -3077
Applicant Contact MARK N SMITH
Correspondent
MDT TECHNOLOGY FOR LIFE
1777 EAST HENRIETTA RD.
P.O. BOX 23077
ROCHESTER,  NY  14692 -3077
Correspondent Contact MARK N SMITH
Regulation Number878.4960
Classification Product Code
FQO  
Date Received03/10/1994
Decision Date 06/10/1994
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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