FDA 510(k) Application Details - K113857

Device Classification Name	Photocoagulator And Accessories   More FDA Info for this Device
510(K) Number	K113857
Device Name	Photocoagulator And Accessories
Applicant	SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'FALLON, MO 63368 US Other 510(k) Applications for this Company
Contact	GARY OLIVEROS Other 510(k) Applications for this Contact
Regulation Number	886.4690   More FDA Info for this Regulation Number
Classification Product Code	HQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2011
Decision Date	04/23/2012
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	N
Expedited Review