BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR

    K Number: K051700 · Decision Aug 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    3
    Review Days
    52

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    Basic Information

    Device Name
    OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR
    K Number
    K051700
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medchannel, LLC
    Date Received
    June 24, 2005
    Decision Date
    August 15, 2005
    Product Code
    GAM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Medchannel, LLC

    K Number Device Name
    K061831 MEDCHANNEL HTS SYSTEM
    K060494 EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM