FDA 510(k) Application Details - K993261

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K993261
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	MITEK PRODUCTS 60 GLACIER DR. WESTWOOD, MA 02090 US Other 510(k) Applications for this Company
Contact	PAULA A BULGER 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	09/29/1999
Decision Date	12/02/1999
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