FDA 510(k) Application Details - K964380

Device Classification Name	Photocoagulator And Accessories   More FDA Info for this Device
510(K) Number	K964380
Device Name	Photocoagulator And Accessories
Applicant	NK-OPTIK AMERICA 1819 SOUTH MAY ST., 2F CHICAGO, IL 60608 US Other 510(k) Applications for this Company
Contact	ROBERT W BAUER, PH.D. Other 510(k) Applications for this Contact
Regulation Number	886.4690   More FDA Info for this Regulation Number
Classification Product Code	HQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/1996
Decision Date	01/22/1997
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