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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K063416
Device Name LUXVISION SLIT LAMP
Applicant
U.S. OPHTHALMIC LLC
7255 NW 68 ST. UNIT #9
MIAMI,  FL  33166
Applicant Contact AL WEISENBORN
Correspondent
U.S. OPHTHALMIC LLC
7255 NW 68 ST. UNIT #9
MIAMI,  FL  33166
Correspondent Contact AL WEISENBORN
Regulation Number886.1850
Classification Product Code
HJO  
Date Received11/13/2006
Decision Date 12/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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