FDA 510(k) Application Details - K123764

Device Classification Name	Implant, Eye Sphere   More FDA Info for this Device
510(K) Number	K123764
Device Name	Implant, Eye Sphere
Applicant	OCULO-PLASTIK, INC. 200, RUE SAUVE OUEST MONTREAL, QC H3L 1Y9 CA Other 510(k) Applications for this Company
Contact	SYLVAIN DESROSIERS 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	12/07/2012
Decision Date	01/31/2013
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