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

    BUSSE SURGICAL DRAPE

    K Number: K082297 · Decision Dec 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    31
    Review Days
    119

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    Basic Information

    Device Name
    BUSSE SURGICAL DRAPE
    K Number
    K082297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Busse Hospital Disposables, Inc.
    Date Received
    August 12, 2008
    Decision Date
    December 9, 2008
    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 Busse Hospital Disposables, Inc.

    K Number Device Name
    K120002 I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
    K093909 BUSSE SURGICAL DRAPES IV
    K092212 BUSSE SURGICAL DRAPES III
    K073222 MODIFICATION TO:SPECIALTY NEEDLES
    K070465 BUSSE EPIDURAL CATHETER
    K063018 GLASS LOSS OF RESISTANCE SYRINGE
    K061394 SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
    K061570 I-STYLE BONE MARROW ASPIRATION NEEDLE
    K052843 BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
    K032432 BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
    Search all 31 clearances from Busse Hospital Disposables, Inc. →