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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 Rd.
Ickleton, Cambridge,  GB CB10 1SX
Applicant Contact LAURA J GARCIA
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
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
Predetermined Change
Control Plan Authorized		 No
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