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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 K080681
Device Name KOWA GENESIS-D
Applicant
KOWA CO. LTD.
4-14, NIHONBASHI-HONCHO
3-CHOME
CHUO-KU, TOKYO,  JP 103-8433
Applicant Contact SATOHIKO TAKANASHI
Correspondent
KOWA CO. LTD.
4-14, NIHONBASHI-HONCHO
3-CHOME
CHUO-KU, TOKYO,  JP 103-8433
Correspondent Contact SATOHIKO TAKANASHI
Regulation Number886.1120
Classification Product Code
HKI  
Date Received03/10/2008
Decision Date 04/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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