FDA 510(k) Application Details - K081565

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K081565
Device Name	Laser, Ophthalmic
Applicant	Ellex Medical Pty. Ltd. 82 GILBERT ST. ADELAIDE, SOUTH AUSTRALIA 5000 AU Other 510(k) Applications for this Company
Contact	KEVIN HOWARD Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	HQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2008
Decision Date	07/02/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review