FDA 510(k) Application Details - K110554

Device Classification Name	Implant, Eye Sphere   More FDA Info for this Device
510(K) Number	K110554
Device Name	Implant, Eye Sphere
Applicant	CERAMISYS LTD. 344 ANNABELLE POINT ROAD CENTERCILLE, MA 02632-2402 US Other 510(k) Applications for this Company
Contact	HILLARD W WELCH Other 510(k) Applications for this Contact
Regulation Number	886.3320   More FDA Info for this Regulation Number
Classification Product Code	HPZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2011
Decision Date	11/02/2011
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