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

    EYE PAD

    K Number: K912955 · Decision Sep 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    270
    Applicant Total
    11
    Review Days
    70

    Basic Information

    Device Name
    EYE PAD
    K Number
    K912955
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    CAL WEST TRADING CO.
    Date Received
    July 2, 1991
    Decision Date
    September 10, 1991
    Product Code
    EFQ
    Advisory Committee
    Unknown
    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
    EFQ Gauze/Sponge, Internal

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    Other Clearances by CAL WEST TRADING CO.

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    K912952 BANDAGE COMPRESS
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    K912951 12-PLY GAUZE PAD
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