FDA 510(k) Application Details - K992978

Device Classification Name	Keratome, Ac-Powered   More FDA Info for this Device
510(K) Number	K992978
Device Name	Keratome, Ac-Powered
Applicant	SURGISTAR, INC. 6068 CORTE DEL CEDRO CARLSBAD, CA 92009 US Other 510(k) Applications for this Company
Contact	JONATHAN WOODWARD 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	09/03/1999
Decision Date	11/16/1999
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