FDA 510(k) Application Details - K012025

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K012025
Device Name	Mesh, Surgical, Polymeric
Applicant	MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	KENNETH K KLEINHENZ Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2001
Decision Date	12/03/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review