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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 K063388
Device Name TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
Applicant
Topcon Corp.
555 Thirteenth St., NW
Columbia Sq.
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Topcon Corp.
555 Thirteenth St., NW
Columbia Sq.
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number886.1570
Classification Product Code
OBO  
Date Received11/08/2006
Decision Date 06/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
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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