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

    KAPPLER PRO/VENT BOOT

    K Number: K932738 · Decision Mar 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    282
    Registration Numbers
    282
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    295

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    Basic Information

    Device Name
    KAPPLER PRO/VENT BOOT
    K Number
    K932738
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kappler, Inc.
    Date Received
    June 7, 1993
    Decision Date
    March 29, 1994
    Product Code
    FXP
    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
    FXP Cover, Shoe, Operating-Room

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    Other Clearances by Kappler, Inc.

    K Number Device Name
    K932694 KAPPLER PRO/VENT PROCEDURE GOWN