FDA 510(k) Application Details - K072102

Device Classification Name	Keratome, Ac-Powered   More FDA Info for this Device
510(K) Number	K072102
Device Name	Keratome, Ac-Powered
Applicant	GEBAUER MEDIZINTECHNIK GMBH 54 FOREST STREET LEXINGTON, MA 02421 US Other 510(k) Applications for this Company
Contact	KIMBERLEY DONEY 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	07/31/2007
Decision Date	01/16/2009
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