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

    MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT

    K Number: K935658 · Decision Mar 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    45
    Applicant Total
    10
    Review Days
    100

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    Basic Information

    Device Name
    MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
    K Number
    K935658
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4780
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Merocel Corp.
    Date Received
    November 24, 1993
    Decision Date
    March 4, 1994
    Product Code
    LYA
    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
    LYA Splint, Intranasal Septal

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