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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 K984602
Device Name SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM
Applicant
Syntec Scientific Corp.
2, Kung San Rd., Chaun Shing
Industrial Zone, Shen Kang
Chang Hua,  TW 509
Applicant Contact TED Y SHI
Correspondent
Syntec Scientific Corp.
2, Kung San Rd., Chaun Shing
Industrial Zone, Shen Kang
Chang Hua,  TW 509
Correspondent Contact TED Y SHI
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/28/1998
Decision Date 03/05/1999
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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