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

    PERCUGUARD

    K Number: K992539 · Decision Feb 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    PERCUGUARD
    K Number
    K992539
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Digit-Pro
    Date Received
    July 30, 1999
    Decision Date
    February 18, 2000
    Product Code
    LZB
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZB Finger Cot

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