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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 K974535
Device Name DISCAM DIGITAL IMAGING SYSTEM
Applicant
Marcher Enterprises, Ltd.
Unit 2 Clearview Ct.Twyford Rd.
Rotherwas Industrial Estate
Hereford, Herefordshire,  GB HR2 6JR
Applicant Contact TIM DAWSON
Correspondent
Marcher Enterprises, Ltd.
Unit 2 Clearview Ct.Twyford Rd.
Rotherwas Industrial Estate
Hereford, Herefordshire,  GB HR2 6JR
Correspondent Contact TIM DAWSON
Regulation Number886.1120
Classification Product Code
HKI  
Date Received12/02/1997
Decision Date 08/14/1998
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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