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

    BTP(TM) CENTRALINE(TM) SUIT

    K Number: K914615 · Decision May 5, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    201

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    Basic Information

    Device Name
    BTP(TM) CENTRALINE(TM) SUIT
    K Number
    K914615
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Btp Industries, Inc.
    Date Received
    October 17, 1991
    Decision Date
    May 5, 1992
    Product Code
    FXO
    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
    FXO Suit, Surgical

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