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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 K023939
Device Name VELOCITY ADVANTAGE
Applicant
Visioncare Devices, Inc.
1246 Redwood Blvd.
Redding,  CA  96003
Applicant Contact CHET CRACCHIOLO
Correspondent
Visioncare Devices, Inc.
1246 Redwood Blvd.
Redding,  CA  96003
Correspondent Contact CHET CRACCHIOLO
Regulation Number886.4150
Classification Product Code
HQE  
Date Received11/26/2002
Decision Date 04/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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