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

    BAYERS BIMANUAL I/A HANDPIECES

    K Number: K971064 · Decision Jun 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    5
    Review Days
    77

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    Basic Information

    Device Name
    BAYERS BIMANUAL I/A HANDPIECES
    K Number
    K971064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Visioncare Devices, Inc.
    Date Received
    March 24, 1997
    Decision Date
    June 9, 1997
    Product Code
    HQC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQC Unit, Phacofragmentation

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    Other Clearances by Visioncare Devices, Inc.

    K Number Device Name
    K120170 PROCARE PLUS VITRECTOMY SYSTEM
    K023939 VELOCITY ADVANTAGE
    K940746 VIT CUTTER MODEL 94
    K904909 I/A VITROPHAGE MODEL YPR 2001