FDA 510(k) Application Details - K191558

Device Classification Name	Microscope, Specular   More FDA Info for this Device
510(K) Number	K191558
Device Name	Microscope, Specular
Applicant	Konan Medical, Inc. 10-29, Miyanishicho Nishinomiya 662-0976 JP Other 510(k) Applications for this Company
Contact	Tatsuya Kasahara Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	NQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2019
Decision Date	03/26/2020
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