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

    DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET

    K Number: K924837 · Decision Oct 12, 1993
    View on FDA
    Classifications
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    80
    Applicant Total
    4
    Review Days
    382

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    Basic Information

    Device Name
    DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET
    K Number
    K924837
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Associated Ent., Inc.
    Date Received
    September 25, 1992
    Decision Date
    October 12, 1993
    Product Code
    LDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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