FDA 510(k) Application Details - K200933

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K200933
Device Name Pin, Fixation, Threaded
Applicant Syntec Scientific Corporation
No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang
Chang Hua 50971 TW
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Contact Nicole Tseng
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 04/07/2020
Decision Date 05/05/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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