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

    MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE

    K Number: K960549 · Decision Aug 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    29
    Applicant Total
    8
    Review Days
    203

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    Basic Information

    Device Name
    MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE
    K Number
    K960549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4340
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neward Enterprises, Inc.
    Date Received
    February 8, 1996
    Decision Date
    August 29, 1996
    Product Code
    HDB
    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
    HDB Extractor, Vacuum, Fetal

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    Other Clearances by Neward Enterprises, Inc.

    K Number Device Name
    K943938 MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE
    K934011 MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
    K925572 MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE
    K913324 MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT
    K910815 CR SPIRAL ELECTRODE
    K890307 MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE
    K840403 VENA * BRIDGE