FDA 510(k) Application Details - K002600

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K002600
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. OKEMOS, MI 48864 US Other 510(k) Applications for this Company
Contact	LANNY L JOHNSON Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2000
Decision Date	11/15/2000
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