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

    BUSSE BAC/SHIELD

    K Number: K902297 · Decision Aug 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    115
    Applicant Total
    31
    Review Days
    86

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    Basic Information

    Device Name
    BUSSE BAC/SHIELD
    K Number
    K902297
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6810
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Busse Hospital Disposables, Inc.
    Date Received
    May 23, 1990
    Decision Date
    August 17, 1990
    Product Code
    BSY
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BSY Catheters, Suction, Tracheobronchial

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    Other Clearances by Busse Hospital Disposables, Inc.

    K Number Device Name
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    K093909 BUSSE SURGICAL DRAPES IV
    K092212 BUSSE SURGICAL DRAPES III
    K082297 BUSSE SURGICAL DRAPE
    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
    Search all 31 clearances from Busse Hospital Disposables, Inc. →