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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K212763
Device Name UniVit HE, UniVit UHS
Applicant
Visioncare Devices, LLC
6100 Bellevue Lane
Anderson,  CA  96007
Applicant Contact Rick Morgan
Correspondent
Visioncare Devices, LLC
6100 Bellevue Lane
Anderson,  CA  96007
Correspondent Contact Rick Morgan
Regulation Number886.4150
Classification Product Code
HQE  
Date Received08/31/2021
Decision Date 08/10/2022
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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