BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BEAVER MICRO-GEM GAUGE BLOCK

    K Number: K860305 · Decision Feb 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    207
    Same Product Code
    53
    Applicant Total
    6
    Review Days
    15

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    Basic Information

    Device Name
    BEAVER MICRO-GEM GAUGE BLOCK
    K Number
    K860305
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Rudolph Beaver, Inc.
    Date Received
    January 28, 1986
    Decision Date
    February 12, 1986
    Product Code
    HNN
    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
    HNN Knife, Ophthalmic

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