FDA 510(k) Application Details - K973015

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K973015
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	BONUTTI RESEARCH 1303 EVERGREEN AVE. EFFINGHAM, IL 62401 US Other 510(k) Applications for this Company
Contact	LYNNETTE WHITAKER 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	08/13/1997
Decision Date	10/09/1997
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