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

    THE STRIPPER

    K Number: K993699 · Decision May 16, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    4
    Review Days
    196

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    Basic Information

    Device Name
    THE STRIPPER
    K Number
    K993699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6130
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mid-Atlantic Diagnostics, Inc.
    Date Received
    November 2, 1999
    Decision Date
    May 16, 2000
    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 Mid-Atlantic Diagnostics, Inc.

    K Number Device Name
    K100596 CRYOPETTE
    K041435 THE STRIPPER PGD
    K030525 CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES