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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image management, ophthalmic
510(k) Number K190056
Device Name KOWA VK-2s
Applicant
KOWA Co. Ltd. CHOFU
3-1, Chofugaoka 3-chome
Chofu,  JP 182-0021
Applicant Contact Rinji Kondo
Correspondent
Ora, Inc.
300 Brickstone Square
Andover,  MA  01810
Correspondent Contact Ryan Bouchard
Regulation Number892.2050
Classification Product Code
NFJ  
Subsequent Product Code
HKI  
Date Received01/11/2019
Decision Date 02/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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