FDA 510(k) Application Details - K993190

Device Classification Name	Keratome, Ac-Powered   More FDA Info for this Device
510(K) Number	K993190
Device Name	Keratome, Ac-Powered
Applicant	SURGICAL INSTRUMENT SYSTEMS (SIS), LTD 18732 SAGINAW IRVINE, CA 92612 US Other 510(k) Applications for this Company
Contact	Judy Gordon Other 510(k) Applications for this Contact
Regulation Number	886.4370   More FDA Info for this Regulation Number
Classification Product Code	HNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/1999
Decision Date	02/10/2000
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