FDA 510(k) Application Details - K090078

Device Classification Name	Prosthesis, Eyelid Spacer/Graft, Biologic   More FDA Info for this Device
510(K) Number	K090078
Device Name	Prosthesis, Eyelid Spacer/Graft, Biologic
Applicant	IOP, INC. 3184-B AIRWAY AVE COSTA MESA, CA 92626 US Other 510(k) Applications for this Company
Contact	JASON MALECKA Other 510(k) Applications for this Contact
Regulation Number	886.3130   More FDA Info for this Regulation Number
Classification Product Code	NXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2009
Decision Date	05/08/2009
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