FDA 510(k) Application Details - K981688

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K981688
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. PALM BEACH GARDENS, FL 33410 US Other 510(k) Applications for this Company
Contact	WILLIAM E ANSPACH, III 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	05/11/1998
Decision Date	07/13/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review