BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PosiSep EAR Fragmentable Ear Dressing

    K Number: K210411 · Decision May 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    14
    Applicant Total
    10
    Review Days
    448

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    Basic Information

    Device Name
    PosiSep EAR Fragmentable Ear Dressing
    K Number
    K210411
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemostasis, LLC
    Date Received
    February 11, 2021
    Decision Date
    May 5, 2022
    Product Code
    NHB
    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
    NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable

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