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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K190573
Device Name KOWA DR-1a
Applicant
Kowa Company , Ltd.
3-1, Chofugaoka 3-Chome
Chofu-Shi,  JP 1820021
Applicant Contact Nariaki Morita
Correspondent
Kowa Company , Ltd.
3-1, Chofugaoka 3-Chome
Chofu-Shi,  JP 1820021
Correspondent Contact Nariaki Morita
Regulation Number886.1120
Classification Product Code
HKI  
Date Received03/06/2019
Decision Date 06/04/2019
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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