FDA 510(k) Application Details - K083342

Device Classification Name	Implant, Eye Sphere   More FDA Info for this Device
510(K) Number	K083342
Device Name	Implant, Eye Sphere
Applicant	EVERA MEDICAL, INC. 353 VINTAGE PARK DRIVE SUITE F FOSTER CITY, CA 94404 US Other 510(k) Applications for this Company
Contact	RANDY KESTEN 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	11/12/2008
Decision Date	03/12/2009
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