BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED

    K Number: K921496 · Decision Aug 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    158

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    Basic Information

    Device Name
    SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
    K Number
    K921496
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5340
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alpine Specialties, Inc.
    Date Received
    March 9, 1992
    Decision Date
    August 14, 1992
    Product Code
    CAT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAT Cannula, Nasal, Oxygen

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    Other Clearances by Alpine Specialties, Inc.

    K Number Device Name
    K912197 SKIN SAVER(TM) TUBING HOLDER, MODEL 467