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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 K093021
Device Name ATLANTIS SLIT LAMP
Applicant
USOPTHALMIC, LLC
19526 EAST LAKE DR.
MIAMI,  FL  33015 -2218
Applicant Contact AL WEISENBORN
Correspondent
USOPTHALMIC, LLC
19526 EAST LAKE DR.
MIAMI,  FL  33015 -2218
Correspondent Contact AL WEISENBORN
Regulation Number886.1850
Classification Product Code
HJO  
Date Received09/29/2009
Decision Date 01/28/2010
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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