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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 K933995
Device Name TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION
Applicant
APPLIED OSTEO SYSTEMS, INC.
1515 OAKLAND BLVD., SUITE 110
WALNUT CREEK,  CA  94596
Applicant Contact MICHAEL A PENTAPOULOS
Correspondent
APPLIED OSTEO SYSTEMS, INC.
1515 OAKLAND BLVD., SUITE 110
WALNUT CREEK,  CA  94596
Correspondent Contact MICHAEL A PENTAPOULOS
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
JDS  
Date Received08/17/1993
Decision Date 01/27/1995
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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