FDA 510(k) Application Details - K010852

Device Classification Name	Expander, Tissue, Orbital   More FDA Info for this Device
510(K) Number	K010852
Device Name	Expander, Tissue, Orbital
Applicant	IOP, INC. 3151 AIRWAY AVE., BLDG. I-1 COSTA MESA, CA 92626 US Other 510(k) Applications for this Company
Contact	JASON MALECKA 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	03/21/2001
Decision Date	08/13/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review