FDA 510(k) Application Details - K121203

Device Classification Name	Keratoprosthesis, Permanent Implant   More FDA Info for this Device
510(K) Number	K121203
Device Name	Keratoprosthesis, Permanent Implant
Applicant	MASSACHUSETTS EYE & EAR INFIRMARY 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	BRIAN J EDWARDS 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	04/20/2012
Decision Date	05/10/2013
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