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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 K093707
Device Name DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
Applicant
U&I Corp.
529-1 Yonghyun-Dong
Uijungbu, Gyeonggi-Do,  KR 480-050
Applicant Contact GYEONG-JE KWON
Correspondent
U&I Corp.
529-1 Yonghyun-Dong
Uijungbu, Gyeonggi-Do,  KR 480-050
Correspondent Contact GYEONG-JE KWON
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HTY  
Date Received12/02/2009
Decision Date 06/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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