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

    GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04

    K Number: K001624 · Decision Jan 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    244

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    Basic Information

    Device Name
    GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
    K Number
    K001624
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gebauer Co.
    Date Received
    May 26, 2000
    Decision Date
    January 25, 2001
    Product Code
    MLY
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MLY Vapocoolant Device

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    Other Clearances by Gebauer Co.

    K Number Device Name
    K032671 GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07
    K031036 GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03
    K021726 GEBAUER'S INSTANT ICE
    K981693 SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
    K002596 GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
    K991514 GEBAUER'S CHLORIDE FINE NOZZE
    K930915 FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE