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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, battery-powered
510(k) Number K061278
Device Name OPTYSE OPHTHALMOSCOPE
Applicant
OPHTHALMOS LTD.
UNIT 1 ABBEY BARNS
DUXFORD ROAD
ICKLETON, CAMBRIDGE,  GB CB10 1SX
Applicant Contact LAURA J GARCIA
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received05/08/2006
Decision Date 05/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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