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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 K120170
Device Name PROCARE PLUS VITRECTOMY SYSTEM
Applicant
Visioncare Devices, Inc.
1246 Redwood Blvd.
Redding,  CA  96003
Applicant Contact KURTIS MONTEGNA
Correspondent
Visioncare Devices, Inc.
1246 Redwood Blvd.
Redding,  CA  96003
Correspondent Contact KURTIS MONTEGNA
Regulation Number886.4150
Classification Product Code
HQE  
Date Received01/19/2012
Decision Date 05/30/2012
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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