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

    STERILE SOLUTION WARMER

    K Number: K833944 · Decision Jan 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    STERILE SOLUTION WARMER
    K Number
    K833944
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    National Fabtronix, Inc.
    Date Received
    November 15, 1983
    Decision Date
    January 25, 1984
    Product Code
    LHC
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LHC Warmer, Irrigation Solution

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    Other Clearances by National Fabtronix, Inc.

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