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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 K000368
Device Name EYECAP IMAGING SYSTEM
Applicant
CLEMENT CLARKE INTL., LTD.
EDINBURGH WAY
HARLOW,  GB CM20 2TT
Applicant Contact M.J. WILKINSON
Correspondent
CLEMENT CLARKE INTL., LTD.
EDINBURGH WAY
HARLOW,  GB CM20 2TT
Correspondent Contact M.J. WILKINSON
Regulation Number886.1120
Classification Product Code
HKI  
Date Received02/04/2000
Decision Date 05/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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