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

    AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS

    K Number: K942158 · Decision Jul 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    14
    Applicant Total
    8
    Review Days
    87

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    Basic Information

    Device Name
    AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
    K Number
    K942158
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5800
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wfr/Aquaplast Corp.
    Date Received
    May 3, 1994
    Decision Date
    July 29, 1994
    Product Code
    EPP
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EPP Splint, Nasal

    Similar 510(k) Clearances

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

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    'EXMOOR' ATKINS NASAL SPLINT

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