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

    SEA-LONG NECKSEAL & HOOD

    K Number: K852345 · Decision Jun 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    20

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    Basic Information

    Device Name
    SEA-LONG NECKSEAL & HOOD
    K Number
    K852345
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Safety Sea Systems, Inc.
    Date Received
    May 31, 1985
    Decision Date
    June 20, 1985
    Product Code
    BYL
    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
    BYL Tent, Oxygen

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