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

    BENDEREV PROTECT-A-PASS NEEDLE

    K Number: K921228 · Decision Sep 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    43
    Applicant Total
    1
    Review Days
    185

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    Basic Information

    Device Name
    BENDEREV PROTECT-A-PASS NEEDLE
    K Number
    K921228
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.4730
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Eimark Labs, Inc.
    Date Received
    March 13, 1992
    Decision Date
    September 14, 1992
    Product Code
    KOA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOA Surgical Instruments, G-U, Manual (And Accessories)

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