FDA 510(k) Application Details - K013756

Device Classification Name	Keratoprosthesis, Permanent Implant   More FDA Info for this Device
510(K) Number	K013756
Device Name	Keratoprosthesis, Permanent Implant
Applicant	ARGUS BIOMEDICAL PTY LTD 3307 CLIFTON AVE., CINCINNATI, OH 45220 US Other 510(k) Applications for this Company
Contact	BARBARA S FANT Other 510(k) Applications for this Contact
Regulation Number	886.3400   More FDA Info for this Regulation Number
Classification Product Code	HQM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2001
Decision Date	08/29/2002
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