FDA 510(k) Application Details - K013760

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K013760
Device Name	Laser, Ophthalmic
Applicant	NIDEK, INC. 21911 ERIE LN. LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	CAROL PATTERSON 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	11/13/2001
Decision Date	02/11/2002
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