FDA 510(k) Application Details - K003299

Device Classification Name	Keratoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K003299
Device Name	Keratoscope, Ac-Powered
Applicant	NIDEK CO., LTD. 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	886.1350   More FDA Info for this Regulation Number
Classification Product Code	HLQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2000
Decision Date	03/09/2001
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review