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

    CUSTOM MEDICAL SUSPENSION STRAP

    K Number: K944988 · Decision Jan 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    107

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    Basic Information

    Device Name
    CUSTOM MEDICAL SUSPENSION STRAP
    K Number
    K944988
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5280
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Custom Medical Specialties, Inc.
    Date Received
    October 12, 1994
    Decision Date
    January 27, 1995
    Product Code
    JAY
    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
    JAY Support, Breathing Tube

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