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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Management, Ophthalmic
510(k) Number K210396
Device Name Harmony Referral System
Applicant
Topcon Healthcare Solutions EMEA Oy
Makelininkatu 43
Oulu,  FI 90100
Applicant Contact Ramya Sundaram
Correspondent
O'Connell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen OConnell
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received02/10/2021
Decision Date 09/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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