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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 K972183
Device Name DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
Applicant
ACE MEDICAL CO.
2260 EAST EL SEGUNDO BLVD.
LOS ANGELES,  CA  90245
Applicant Contact KATHLEEN A DRAGOVICH
Correspondent
ACE MEDICAL CO.
2260 EAST EL SEGUNDO BLVD.
LOS ANGELES,  CA  90245
Correspondent Contact KATHLEEN A DRAGOVICH
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/10/1997
Decision Date 08/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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