FDA 510(k) Application Details - K093305

Device Classification Name	Vitrectomy, Instrument Cutter   More FDA Info for this Device
510(K) Number	K093305
Device Name	Vitrectomy, Instrument Cutter
Applicant	ALCON RESEARCH, LTD. 15800 ALTON PARKWAY IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	MARTIN A KAUFMAN Other 510(k) Applications for this Contact
Regulation Number	886.4150   More FDA Info for this Regulation Number
Classification Product Code	MLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2009
Decision Date	04/02/2010
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