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

    HEMO-STAT

    K Number: K922636 · Decision Nov 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    164

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    Basic Information

    Device Name
    HEMO-STAT
    K Number
    K922636
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mckinley-Ross Laboratories, Inc.
    Date Received
    May 29, 1992
    Decision Date
    November 9, 1992
    Product Code
    SEJ
    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
    SEJ Wound Dressings Containing Topical Analgesics

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