FDA 510(k) Application Details - K040689

Device Classification Name	Implant, Eye Sphere   More FDA Info for this Device
510(K) Number	K040689
Device Name	Implant, Eye Sphere
Applicant	OCULO PLASTIK, INC. 200 SAUVE WEST MONTREAL, QUEBEC H3L 1Y9 CA Other 510(k) Applications for this Company
Contact	JEAN-FRANCOIS DRETTE 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	03/16/2004
Decision Date	06/10/2004
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