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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 K071839
Device Name SOCT COPERNICUS, MODEL 15205
Applicant
Reichert, Inc.
3362 Walden Ave.
Depew,  NY  14043
Applicant Contact SANDRA BROWN
Correspondent
Reichert, Inc.
3362 Walden Ave.
Depew,  NY  14043
Correspondent Contact SANDRA BROWN
Regulation Number886.1570
Classification Product Code
OBO  
Date Received07/05/2007
Decision Date 02/27/2008
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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