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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Surgical, Ac-Powered
510(k) Number K964102
Device Name TENET TIBIAL FRACTURE SUPPORT
Applicant
Tenet Medical Engineering
2nd. Floor 2004 - 10 Ave. SW
Calgary Alberta,  CA T3C OJ8
Applicant Contact KEN MOORE
Correspondent
Tenet Medical Engineering
2nd. Floor 2004 - 10 Ave. SW
Calgary Alberta,  CA T3C OJ8
Correspondent Contact KEN MOORE
Regulation Number878.4960
Classification Product Code
GBB  
Subsequent Product Code
GDC  
Date Received10/11/1996
Decision Date 12/05/1996
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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