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

    EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD

    K Number: K964855 · Decision Mar 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    78
    Same Product Code
    46
    Applicant Total
    13
    Review Days
    90

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    Basic Information

    Device Name
    EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
    K Number
    K964855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4790
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shippert Medical Technologies Corp.
    Date Received
    December 4, 1996
    Decision Date
    March 4, 1997
    Product Code
    HOZ
    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
    HOZ Sponge, Ophthalmic

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