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

    AUTO SUTURE PSS SKIN STAPLING INSTRUMENT

    K Number: K810187 · Decision Mar 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    3
    Applicant Total
    218
    Review Days
    57

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    Basic Information

    Device Name
    AUTO SUTURE PSS SKIN STAPLING INSTRUMENT
    K Number
    K810187
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    January 22, 1981
    Decision Date
    March 20, 1981
    Product Code
    KBC
    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
    KBC Saw, Nasal

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