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

    ALL-HANDS TRACHEOSTOMY CARE SET 0101

    K Number: K842415 · Decision Jul 6, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    3
    Review Days
    16

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    Basic Information

    Device Name
    ALL-HANDS TRACHEOSTOMY CARE SET 0101
    K Number
    K842415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    All-Hands Medical Supply, Inc.
    Date Received
    June 20, 1984
    Decision Date
    July 6, 1984
    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 All-Hands Medical Supply, Inc.

    K Number Device Name
    K842953 ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL
    K842545 ALL-HANDS STERILE FIELD-0201