FDA 510(k) Application Details - K082043

Device Classification Name	Keratome, Ac-Powered   More FDA Info for this Device
510(K) Number	K082043
Device Name	Keratome, Ac-Powered
Applicant	SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG MAINPARKSTRASSE 6-10 KLEINOSTHEIM 63801 DE Other 510(k) Applications for this Company
Contact	ROLF SCHWIND 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	07/18/2008
Decision Date	08/01/2008
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	Y
Expedited Review