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

    JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT

    K Number: K925469 · Decision May 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    916

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    Basic Information

    Device Name
    JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT
    K Number
    K925469
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    J.J. Skinner, Inc.
    Date Received
    October 29, 1992
    Decision Date
    May 3, 1995
    Product Code
    FKG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FKG Tray, Start/Stop (Including Contents), Dialysis

    Similar 510(k) Clearances

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

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    ACUTE RENAL DIALYSIS TRAY

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    Other Clearances by J.J. Skinner, Inc.

    K Number Device Name
    K961227 JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY
    K961683 JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY
    K925467 JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT
    K925468 JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT
    K903545 CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS
    K903544 CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS