BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    UNICARE BREAST SHELLS

    K Number: K861608 · Decision Jul 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    77

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    Basic Information

    Device Name
    UNICARE BREAST SHELLS
    K Number
    K861608
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5630
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Unicare Medical Products, Inc.
    Date Received
    April 29, 1986
    Decision Date
    July 15, 1986
    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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