FDA 510(k) Application Details - K002515

Device Classification Name	Keratome, Ac-Powered   More FDA Info for this Device
510(K) Number	K002515
Device Name	Keratome, Ac-Powered
Applicant	MED-LOGICS, INC. 30001 GOLDEN LANTERN #334 LAGUNA NIGUEL, CA 92677 US Other 510(k) Applications for this Company
Contact	GARY MOCNIK 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	08/15/2000
Decision Date	02/22/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review