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

    BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES

    K Number: K092554 · Decision Apr 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    253

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    Basic Information

    Device Name
    BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES
    K Number
    K092554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6130
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunlight Medical, Inc.
    Date Received
    August 20, 2009
    Decision Date
    April 30, 2010
    Product Code
    MQH
    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
    MQH Microtools, Assisted Reproduction (Pipettes)

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    Other Clearances by Sunlight Medical, Inc.

    K Number Device Name
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