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

    SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP

    K Number: K800511 · Decision Apr 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    291
    Registration Numbers
    291
    Same Product Code
    31
    Applicant Total
    19
    Review Days
    42

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    Basic Information

    Device Name
    SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP
    K Number
    K800511
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Convertors Div., American Pharmaseal
    Date Received
    March 5, 1980
    Decision Date
    April 16, 1980
    Product Code
    FYF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FYF Cap, Surgical

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