FDA 510(k) Application Details - K112952

Device Classification Name	Applicator, Ocular Pressure   More FDA Info for this Device
510(K) Number	K112952
Device Name	Applicator, Ocular Pressure
Applicant	ORYX MEDICAL PTY LTD UNIT 4/43 CALEDONIAN AVENUE MAYLANDS 6051 AT Other 510(k) Applications for this Company
Contact	ANNE F JONES Other 510(k) Applications for this Contact
Regulation Number	886.4610   More FDA Info for this Regulation Number
Classification Product Code	LCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2011
Decision Date	05/10/2012
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