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

    ALBA HEALTH PAS WRAP SYSTEM

    K Number: K961405 · Decision Dec 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    8
    Review Days
    259

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    Basic Information

    Device Name
    ALBA HEALTH PAS WRAP SYSTEM
    K Number
    K961405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alba-Waldensian, Inc.
    Date Received
    April 11, 1996
    Decision Date
    December 26, 1996
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Alba-Waldensian, Inc.

    K Number Device Name
    K020592 ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
    K852091 ALBA DRY BURN PAD
    K792357 STERILE IMPERVIOUS ORTHOPEDIC STOCKIN
    K781964 COMPRESSION DEVICES, LIMB
    K780570 TUBULAR DRESSING RETAINER
    K780547 STERILE ORTHOPEDIC STOCKINETTE
    K771913 HEEL/ELBOW PROTECTOR