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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 K200954
Device Name Glaucoma Module
Applicant
Topcon Healthcare Solutions, Inc.
111 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact Ramya Sundaram
Correspondent
O'Connell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received04/09/2020
Decision Date 08/03/2020
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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