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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K911554
Device Name AIM TIBIAL NAIL
Applicant
Ace Medical Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Applicant Contact GLORIA TESKE
Correspondent
Ace Medical Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Correspondent Contact GLORIA TESKE
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/09/1991
Decision Date 07/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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