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

    SATO FAMILY FIRST AID KIT

    K Number: K831706 · Decision Jun 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    20
    Applicant Total
    2
    Review Days
    29

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SATO FAMILY FIRST AID KIT
    K Number
    K831706
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3640
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Food and Drug Service, Inc.
    Date Received
    May 26, 1983
    Decision Date
    June 24, 1983
    Product Code
    ILI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILI Sling, Arm

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ILI), ordered by most recent decision date.

    MATRX, PYRAMID TRIANGLE BANDAGE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ARM SLINGS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    VARIOUS ARM SLING

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    A.C. SPLINT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    UNIVERSAL SLING, SLING & SWATHE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    UNIVERSAL SLING, SLING & SWATHE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Food and Drug Service, Inc.

    K Number Device Name
    K823076 SATOBAN FIRST AID TAPE