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

    MEROCEL REINFORCED SILICONE SHEETS

    K Number: K953013 · Decision Aug 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    32
    Applicant Total
    10
    Review Days
    61

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    Basic Information

    Device Name
    MEROCEL REINFORCED SILICONE SHEETS
    K Number
    K953013
    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
    Merocel Corp.
    Date Received
    June 29, 1995
    Decision Date
    August 29, 1995
    Product Code
    KHJ
    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
    KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

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    ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN

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