FDA 510(k) Application Details - K060151

Device Classification Name	Expander, Tissue, Orbital   More FDA Info for this Device
510(K) Number	K060151
Device Name	Expander, Tissue, Orbital
Applicant	INNOVIA, LLC 12415 SW 136 AVENUE UNIT 3 MIAMI, FL 33186 US Other 510(k) Applications for this Company
Contact	STEWART B DAVIS Other 510(k) Applications for this Contact
Regulation Number	886.3320   More FDA Info for this Regulation Number
Classification Product Code	NFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2006
Decision Date	08/08/2006
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