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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 K983757
Device Name SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01
Applicant
SYNTEC SCIENTIFIC CORP.
2, KUNG SAN ROAD, CHAUN SHING
INDUSTRIAL ZONE, SHEN KANG
CHANG HUA,  TW 509
Applicant Contact TED Y SHI
Correspondent
SYNTEC SCIENTIFIC CORP.
2, KUNG SAN ROAD, CHAUN SHING
INDUSTRIAL ZONE, SHEN KANG
CHANG HUA,  TW 509
Correspondent Contact TED Y SHI
Regulation Number888.3040
Classification Product Code
JDW  
Date Received10/23/1998
Decision Date 12/04/1998
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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