BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L

    K Number: K991396 · Decision Feb 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    253
    Applicant Total
    6
    Review Days
    300

    Basic Information

    Device Name
    WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
    K Number
    K991396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SAGE BIOPHARMA
    Date Received
    April 21, 1999
    Decision Date
    February 15, 2000
    Product Code
    MQL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQL Media, Reproductive

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