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

    SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY

    K Number: K010933 · Decision Jan 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    1
    Review Days
    286

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    Basic Information

    Device Name
    SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY
    K Number
    K010933
    Device Class
    FDA unclassified
    Clearance Type
    Abbreviated
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alltracel Pharma , Ltd.
    Date Received
    March 28, 2001
    Decision Date
    January 8, 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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