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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 K091683
Device Name KOWA VX-10 A
Applicant
KOWA CO. LTD.
4-14, NIHONBASHI-HONCHO
3-CHOME
CHUO-KU, TOKYO,  JP 103-8433
Applicant Contact AKIHIRO FUJITA
Correspondent
KOWA CO. LTD.
4-14, NIHONBASHI-HONCHO
3-CHOME
CHUO-KU, TOKYO,  JP 103-8433
Correspondent Contact AKIHIRO FUJITA
Regulation Number886.1120
Classification Product Code
HKI  
Date Received06/10/2009
Decision Date 07/02/2009
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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