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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 K963506
Device Name TENET RADIOLUCENT HAND TABLE
Applicant
TENET MEDICAL ENGINEERING
3553 31ST ST., N.W.
CALGARY,  CA T2L 2K7
Applicant Contact KEN MOORE
Correspondent
TENET MEDICAL ENGINEERING
3553 31ST ST., N.W.
CALGARY,  CA T2L 2K7
Correspondent Contact KEN MOORE
Regulation Number878.4960
Classification Product Code
FQO  
Subsequent Product Codes
FWW   GDC  
Date Received09/03/1996
Decision Date 01/09/1997
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
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