FDA 510(k) Application Details - K023643

Device Classification Name	Wrap, Implant, Orbital   More FDA Info for this Device
510(K) Number	K023643
Device Name	Wrap, Implant, Orbital
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	886.3320   More FDA Info for this Regulation Number
Classification Product Code	MTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2002
Decision Date	02/21/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review