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

    ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC.

    K Number: K932857 · Decision Sep 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    5
    Review Days
    95

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    Basic Information

    Device Name
    ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC.
    K Number
    K932857
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ansley Medical Products, Inc.
    Date Received
    June 10, 1993
    Decision Date
    September 13, 1993
    Product Code
    KKX
    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
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Ansley Medical Products, Inc.

    K Number Device Name
    K925290 CATALOG NUMBER 111 (FACESHIELD)
    K924567 FOLEY CATHETER TUBE HOLDER NO. 101
    K924568 TUBE, LEAD, AND CORD HOLDER NO. 102
    K924566 RESTRAINT, PROTECTIVE N0. 103