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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 K172830
Device Name Double Medical Femoral Nail System
Applicant
Double Medical Technology, Inc.
# 18, Shanbianhong E. Rd., Haicang District
Xiamen,  CN
Applicant Contact Yan Zuo
Correspondent
Double Medical Technology, Inc.
# 18, Shanbianhong E. Rd., Haicang District
Xiamen,  CN
Correspondent Contact Yan Zuo
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received09/18/2017
Decision Date 08/24/2018
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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