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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Specular
510(k) Number K191558
Device Name Konan Specular Microscope XVII
Applicant
Konan Medical, Inc.
10-29, Miyanishicho
Nishinomiya,  JP 662-0976
Applicant Contact Tatsuya Kasahara
Correspondent
Matrix Medical Consulting, Inc.
8880 Rio San Diego Dr. Suite 800
San Diego,  CA  92108
Correspondent Contact Alan Donald
Regulation Number886.1850
Classification Product Code
NQE  
Date Received06/12/2019
Decision Date 03/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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