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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K133755
Device Name KOWA SL-17
Applicant
Kowa Co. , Ltd.
4-14, Nihonbashi-Honcho 3-Chome
Chuo-Ku, Tokyo,  JP 103-8433
Applicant Contact HIROYUKI KOIDE
Correspondent
Kowa Company , Ltd.
3-1, Chofugaoka 3-Chome
Chofu,  JP 182-0021
Correspondent Contact Nariaki Morita
Regulation Number886.1850
Classification Product Code
HJO  
Date Received12/09/2013
Decision Date 03/11/2014
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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