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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K111531
Device Name RHA2020
Applicant
Annidis Health Systems Corp.
2650 Queensview Dr.
Suite 245
Ottawa, Ontario,  CA K2B 8H6
Applicant Contact MICHAEL MCDONNELL
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number886.1570
Classification Product Code
HLI  
Subsequent Product Code
HKI  
Date Received06/02/2011
Decision Date 07/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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