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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 K060869
Device Name RS-1000 ZOOM SLITLAMP WITH OPTION
Applicant
Rightmedical Products, LLC
200 Expy. Ct.
Virginia Beach,  VA  23462
Applicant Contact HARUMI KUMAHARA
Correspondent
Rightmedical Products, LLC
200 Expy. Ct.
Virginia Beach,  VA  23462
Correspondent Contact HARUMI KUMAHARA
Regulation Number886.1850
Classification Product Code
HJO  
Date Received03/30/2006
Decision Date 05/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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