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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 K873157
Device Name OXFORD RETRO-ILLUMINATION CATARACT CAMERA
Applicant
Holofax , Ltd.
Netherwood Rd.
Rotherwas, Hereford
England,  GB HR2 6JZ
Applicant Contact DAWSON
Correspondent
Holofax , Ltd.
Netherwood Rd.
Rotherwas, Hereford
England,  GB HR2 6JZ
Correspondent Contact DAWSON
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/10/1987
Decision Date 09/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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