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

    INVITRO MATURATION MEDIA

    K Number: K053646 · Decision Jul 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    2
    Review Days
    196

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    Basic Information

    Device Name
    INVITRO MATURATION MEDIA
    K Number
    K053646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sage In-Vitro Fertilization, Inc.
    Date Received
    December 30, 2005
    Decision Date
    July 14, 2006
    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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    Other Clearances by Sage In-Vitro Fertilization, Inc.

    K Number Device Name
    K073522 VITRIFICATION KIT & VITRIFICATION WARMING KIT