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

    COMPRESSION LEGGING DEVICE

    K Number: K871889 · Decision Aug 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    81

    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
    COMPRESSION LEGGING DEVICE
    K Number
    K871889
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    A-T Surgical Mfg. Co., Inc.
    Date Received
    May 15, 1987
    Decision Date
    August 4, 1987
    Product Code
    LLK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLK Legging, Compression, Non-Inflatable

    Similar 510(k) Clearances

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

    UNNA-SLEEVE(TM)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TECNOL COMPRESSION KNEE DRESSING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODEL 1888 ALPHA COS/RESPIRATION CAR

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by A-T Surgical Mfg. Co., Inc.

    K Number Device Name
    K843793 A-T TENS BELT