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

    PREPACELL-STERILE-BONE MARROW ASPIR

    K Number: K833438 · Decision Feb 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    330
    Same Product Code
    61
    Applicant Total
    11
    Review Days
    127

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    Basic Information

    Device Name
    PREPACELL-STERILE-BONE MARROW ASPIR
    K Number
    K833438
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Applied Medical Devices, Inc.
    Date Received
    October 5, 1983
    Decision Date
    February 9, 1984
    Product Code
    KDD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KDD Kit, Surgical Instrument, Disposable

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    Other Clearances by Applied Medical Devices, Inc.

    K Number Device Name
    K843885 PERCUTANEOUS ASPIRATION BIOPSY TRAY
    K843884 GENERAL UTILITY TRAY SYSTEM
    K843883 STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN
    K840904 ACCU-CULT FECAL OCCULT BLOOD TEST
    K842591 ULTRASOUND PROBE COVERS-STERILE
    K833720 TRANSTHORACIC/TRANSABDOMINAL-TRAY
    K840334 CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY
    K833719 PREPACELL THIN NEEDLE ASPIRATION TRAY
    K802406 CYTOTRAN I BONE MARROW ASPIRATION SYSTEM
    K791660 PREPACELL-BONE MARROW SAMPLER
    Search all 11 clearances from Applied Medical Devices, Inc. →