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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 K221221
Device Name Advanced Intramedullary Nail System
Applicant
Double Medical Technology, Inc.
# 18, Shanbianhong E. Rd., Haicang District
Xiamen,  CN 361026
Applicant Contact Yan Zuo
Correspondent
Double Medical Technology, Inc.
# 18, Shanbianhong E. Rd., Haicang District
Xiamen,  CN 361026
Correspondent Contact Yan Zuo
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/27/2022
Decision Date 12/21/2022
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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