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

    POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS

    K Number: K925077 · Decision Aug 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    313

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    Basic Information

    Device Name
    POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS
    K Number
    K925077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medtek Development Corp.
    Date Received
    October 7, 1992
    Decision Date
    August 16, 1993
    Product Code
    FYC
    Advisory Committee
    General, Plastic Surgery
    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
    FYC Gown, Isolation, Surgical

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    Other Clearances by Medtek Development Corp.

    K Number Device Name
    K930026 POLY-MED DISPOSABLE PERSONAL PROTECTION KIT