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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K072971
Device Name TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
Applicant
Topcon Medical Systems, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Topcon Medical Systems, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number886.1570
Classification Product Code
OBO  
Date Received10/22/2007
Decision Date 01/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT00792259
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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