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

    H-H FLUSHING RESERVOIR

    K Number: K875287 · Decision Jul 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    42
    Review Days
    198

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    Basic Information

    Device Name
    H-H FLUSHING RESERVOIR
    K Number
    K875287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Holter-Hausner Intl.
    Date Received
    December 29, 1987
    Decision Date
    July 14, 1988
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

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    Other Clearances by Holter-Hausner Intl.

    K Number Device Name
    K874508 H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
    K872285 H-H HUNTER ACTIVE TENDON IMPLANT DC
    K872284 H-H HUNTER ACTIVE TENDON IMPLANT PC
    K872293 H-H HUNTER ACTIVE TENDON IMPLANT BC
    K871351 H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
    K870660 H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
    K865075 H-H SUBGALEAL TROCAR
    K853436 H-H HUNTER PASSIVE TENDON IMPLANT
    K853437 H-H HUNTER TENDON ROD
    K853438 H-H HUNTER ACTIVE TENDON IMPLANT
    Search all 42 clearances from Holter-Hausner Intl. →