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

    HEMOSORB

    K Number: K021581 · Decision Jul 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    9
    Review Days
    59

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    Basic Information

    Device Name
    HEMOSORB
    K Number
    K021581
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    On Site Gas Systems, Inc.
    Date Received
    May 14, 2002
    Decision Date
    July 12, 2002
    Product Code
    QSY
    Advisory Committee
    Unknown
    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
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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    Other Clearances by On Site Gas Systems, Inc.

    K Number Device Name
    K092636 POGS, MODEL 65/130
    K063454 POGS, MODEL 33C
    K041664 PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C
    K030920 POGS 33
    K013390 QUICKCLOT
    K021082 ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0
    K020362 P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM
    K014078 ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM