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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K151458
Device Name Double Medical Universal Spine System
Applicant
Double Medical Technology, Inc.
# 18 Shanbianhong E. Rd., Haicang District
Xiamen,  CN 361022
Applicant Contact DA ZENG
Correspondent
Double Medical Technology, Inc.
# 18, Shanbianhong E. Rd., Haicang District
Xiamen,  CN 361026
Correspondent Contact DA ZENG
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received06/01/2015
Decision Date 08/22/2016
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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