FDA 510(k) Application Details - K082850

Device Classification Name	Implant, Eye Sphere   More FDA Info for this Device
510(K) Number	K082850
Device Name	Implant, Eye Sphere
Applicant	PRODUCT AND EDUCATIONAL SERVICES LLC 3805 OLD EASTON ROAD DOLYESTOWN, PA 18902 US Other 510(k) Applications for this Company
Contact	EDWARD GRIFFITH 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	09/29/2008
Decision Date	02/27/2009
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