FDA 510(k) Application Details - K000327

Device Classification Name	Refractometer, Ophthalmic   More FDA Info for this Device
510(K) Number	K000327
Device Name	Refractometer, Ophthalmic
Applicant	VISX, INCORPORATED 3400 CENTRAL EXPRESSWAY SANTA CLARA, CA 95051-0703 US Other 510(k) Applications for this Company
Contact	DAVID M PATINO Other 510(k) Applications for this Contact
Regulation Number	886.1760   More FDA Info for this Regulation Number
Classification Product Code	HKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2000
Decision Date	05/02/2000
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