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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K200933
Device Name Syntec Non-Sterile Steinmann Pins System
Applicant
Syntec Scientific Corporation
#2, Kung San Rd. Chuan Shing Industrial Zone, Shen Kang
Chang Hua,  TW 50971
Applicant Contact Nicole Tseng
Correspondent
Syntec Scientific Corporation - Taipei Office
3f., # 96, Sec. 3, Zhongxio E. Rd. Da'An Dist.
Taipei,  TW 10652
Correspondent Contact Nicole Tseng
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
HTY  
Date Received04/07/2020
Decision Date 05/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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