FDA 510(k) Application Details - K003076

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K003076
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	MITEK PRODUCTS 249 VANDERBILT AVE. NORWOOD, MA 02062 US Other 510(k) Applications for this Company
Contact	CHRISTINE KUNTZ-NASSIF Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	MAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2000
Decision Date	10/27/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review