FDA 510(k) Application Details - K081877

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K081877
Device Name	Unit, Phacofragmentation
Applicant	DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEG 2 ZUIDLAND 3214 VN NL Other 510(k) Applications for this Company
Contact	GER VIJFVINKEL Other 510(k) Applications for this Contact
Regulation Number	886.4670   More FDA Info for this Regulation Number
Classification Product Code	HQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2008
Decision Date	01/05/2009
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