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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 K182376
Device Name Harmony
Topcon Medical Systems, Inc.
111 Bauer Drive
Oakland,  NJ  07436
Applicant Contact James Lorkowski
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number892.2050
Classification Product Code
Date Received08/31/2018
Decision Date 09/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No