FDA 510(k) Application Details - K983873

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K983873
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG CHANG HUA 509 TW Other 510(k) Applications for this Company
Contact	TED Y SHI Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/1998
Decision Date	12/30/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review