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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K221088
Device Name Anatomic Bone Plate
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 Number888.3030
Classification Product Code
HRS  
Date Received04/13/2022
Decision Date 01/18/2023
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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