FDA 510(k) Application Details - K962661

Device Classification Name	Keratome, Ac-Powered   More FDA Info for this Device
510(K) Number	K962661
Device Name	Keratome, Ac-Powered
Applicant	MED-LOGICS, INC. 9327 BLACKLEY ST. TEMPLE CITY, CA 91780 US Other 510(k) Applications for this Company
Contact	GLENN A DUNKIN-JACOBS 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	07/08/1996
Decision Date	12/09/1996
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