FDA 510(k) Application Details - K182646

Device Classification Name	Photocoagulator And Accessories   More FDA Info for this Device
510(K) Number	K182646
Device Name	Photocoagulator And Accessories
Applicant	Vitreq B.V. Segglant-Noord 2 Vierpolders 3237MG NL Other 510(k) Applications for this Company
Contact	JanKees Wouts 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	09/24/2018
Decision Date	05/01/2019
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