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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 K080460
Device Name SPECTRAL OCT/SLO
Applicant
Opko Health, Inc.
4400 Biscayne Blvd.
Miami,  FL  33137
Applicant Contact JANE HSIAO
Correspondent
Opko Health, Inc.
4400 Biscayne Blvd.
Miami,  FL  33137
Correspondent Contact JANE HSIAO
Regulation Number886.1570
Classification Product Code
OBO  
Date Received02/20/2008
Decision Date 11/14/2008
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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