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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 K133081
Device Name TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N
Applicant
Advanced Orthopaedic Solutions, Inc.
3203 Kashiwa St.
Torrance,  CA  90505
Applicant Contact KAZUNORI MIYAHARA
Correspondent
Advanced Orthopaedic Solutions, Inc.
3203 Kashiwa St.
Torrance,  CA  90505
Correspondent Contact KAZUNORI MIYAHARA
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/30/2013
Decision Date 12/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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