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

    PREPACELL-BONE MARROW SAMPLER

    K Number: K791660 · Decision Sep 12, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    11
    Review Days
    22

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    Basic Information

    Device Name
    PREPACELL-BONE MARROW SAMPLER
    K Number
    K791660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Applied Medical Devices, Inc.
    Date Received
    August 21, 1979
    Decision Date
    September 12, 1979
    Product Code
    FMF
    Advisory Committee
    General Hospital
    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
    FMF Syringe, Piston

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    Other Clearances by Applied Medical Devices, Inc.

    K Number Device Name
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    K840904 ACCU-CULT FECAL OCCULT BLOOD TEST
    K842591 ULTRASOUND PROBE COVERS-STERILE
    K833720 TRANSTHORACIC/TRANSABDOMINAL-TRAY
    K840334 CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY
    K833438 PREPACELL-STERILE-BONE MARROW ASPIR
    K833719 PREPACELL THIN NEEDLE ASPIRATION TRAY
    K802406 CYTOTRAN I BONE MARROW ASPIRATION SYSTEM
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