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

    TRACH TAPE

    K Number: K820099 · Decision Feb 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    127
    Applicant Total
    20
    Review Days
    41

    Basic Information

    Device Name
    TRACH TAPE
    K Number
    K820099
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    STAN-PAK ENT.
    Date Received
    January 13, 1982
    Decision Date
    February 23, 1982
    Product Code
    BTO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by STAN-PAK ENT.

    K Number Device Name
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    K820155 SPECIALIST CAST PADDING
    K820108 TOPPER SPONGES
    K820107 GUAZE SPONGES, PLAIN
    K820140 WEBRIL CAST PADDING
    K820056 TELFA STRIPS
    K820142 TUBULAR STOCKINETTE
    K820105 COMBINE PAD OR ABD
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