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

    MEDICOOL PROTECTALL

    K Number: K934703 · Decision Jan 26, 1994
    View on FDA
    Classifications
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    80
    Applicant Total
    1
    Review Days
    118

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    Basic Information

    Device Name
    MEDICOOL PROTECTALL
    K Number
    K934703
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Avc Regulatory Compliance/Technical Services
    Date Received
    September 30, 1993
    Decision Date
    January 26, 1994
    Product Code
    LDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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