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

    BOTTLE-TO-BOTTLE

    K Number: K811268 · Decision Jun 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    12
    Review Days
    44

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    Basic Information

    Device Name
    BOTTLE-TO-BOTTLE
    K Number
    K811268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medi-Plast Intl., Inc.
    Date Received
    May 5, 1981
    Decision Date
    June 18, 1981
    Product Code
    KPE
    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
    KPE Container, I.V.

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    Other Clearances by Medi-Plast Intl., Inc.

    K Number Device Name
    K954284 MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)
    K873588 10CC CONTROL SYRINGE
    K863402 MEDI-PLAST DISPOSABLE MANIFOLD
    K861785 FLUOROSCOPE BAND BAG
    K851489 ARTERIAL-VENOUS COMPRESSION DRESSING
    K842136 STERILE PAN SET
    K840021 OPERATING ROOM TRAY SET
    K840022 HEART CATHETERIZATION TRAY SET
    K811234 I.V. BOTTLE (RIDGID)
    K811233 I.V. PLASTIC BAG
    Search all 12 clearances from Medi-Plast Intl., Inc. →