FDA 510(k) Application Details - K043613

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K043613
Device Name	Laser, Ophthalmic
Applicant	QUANTEL MEDICAL 342 SUNSET BAY RD. HOT SPRINGS, AR 71913 US Other 510(k) Applications for this Company
Contact	ROGER W BARNES 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	12/30/2004
Decision Date	03/24/2005
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