FDA 510(k) Application Details - K983988

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K983988
Device Name	Plate, Fixation, Bone
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	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/1998
Decision Date	01/27/1999
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