FDA 510(k) Application Details - K990665

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K990665
Device Name	Laser, Ophthalmic
Applicant	AMERICAN LASER CORP. 2417 SOUTH 3850 WEST SALT LAKE CITY, UT 84120 US Other 510(k) Applications for this Company
Contact	DANIEL HOEFER 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	03/02/1999
Decision Date	05/17/1999
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