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

    LAPAROMED LIGATING LOOP

    K Number: K921053 · Decision Aug 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    3
    Applicant Total
    10
    Review Days
    154

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    Basic Information

    Device Name
    LAPAROMED LIGATING LOOP
    K Number
    K921053
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5220
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laparomed Corp.
    Date Received
    March 5, 1992
    Decision Date
    August 6, 1992
    Product Code
    KCJ
    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
    KCJ Applicator, Ent

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