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

    STERI-LUB LUBRICATION GEL

    K Number: K083189 · Decision Nov 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    48
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    STERI-LUB LUBRICATION GEL
    K Number
    K083189
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avail Medical Products, Inc.
    Date Received
    October 29, 2008
    Decision Date
    November 21, 2008
    Product Code
    KMJ
    Advisory Committee
    General Hospital
    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
    KMJ Lubricant, Patient

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    Other Clearances by Avail Medical Products, Inc.

    K Number Device Name
    K112209 PREFILLED CATHETER INFLATION SYRINGE
    K090121 PRE-FILLED CATHETER INFLATION SYRINGE
    K030149 MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9
    K030137 MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9