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

    COMFORT PLUS BREAST SHELLS

    K Number: K935341 · Decision Jan 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    77

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    Basic Information

    Device Name
    COMFORT PLUS BREAST SHELLS
    K Number
    K935341
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5630
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Marshall Baby Products
    Date Received
    November 5, 1993
    Decision Date
    January 21, 1994
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HFS), ordered by most recent decision date.

    BREAST SHELL

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    COMFORT PLUS NIPPLE SHIELDS

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    FDA Class 1 ·General Hospital

    BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS

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    FDA Class 1 ·General Hospital

    BREAST SHELLS

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    FDA Class 1 ·General Hospital

    GENTLE FEEL

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    Other Clearances by Marshall Baby Products

    K Number Device Name
    K935340 COMFORT PLUS NIPPLE SHIELDS