FDA 510(k) Application Details - K121675

Device Classification Name	Instrument, Vitreous Aspiration And Cutting, Ac-Powered   More FDA Info for this Device
510(K) Number	K121675
Device Name	Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant	SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'FALLON, MO 63368 US Other 510(k) Applications for this Company
Contact	DAN REGAN Other 510(k) Applications for this Contact
Regulation Number	886.4150   More FDA Info for this Regulation Number
Classification Product Code	HQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2012
Decision Date	06/21/2012
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