BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AXICARE BREAST SHELL

    K Number: K811364 · Decision Aug 3, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    11
    Applicant Total
    3
    Review Days
    81

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    Basic Information

    Device Name
    AXICARE BREAST SHELL
    K Number
    K811364
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5630
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Neonatal Corp.
    Date Received
    May 14, 1981
    Decision Date
    August 3, 1981
    Product Code
    HFS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HFS Shield, Nipple

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    Other Clearances by Neonatal Corp.

    K Number Device Name
    K811707 AXICUT DISPOSABLE SCALPEL
    K811403 AXICARE BREAST PUMP MODEL