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

    BREAST SHELL

    K Number: K944177 · Decision Oct 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    40

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BREAST SHELL
    K Number
    K944177
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5630
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    O'Donnell, Byrne & Williams
    Date Received
    August 26, 1994
    Decision Date
    October 5, 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.

    AVENT NIPPLE SHIELD

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COMFORT PLUS BREAST SHELLS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COMFORT PLUS NIPPLE SHIELDS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BREAST SHELLS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GENTLE FEEL

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all