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

    CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS

    K Number: K903544 · Decision Aug 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    285
    Registration Numbers
    286
    Same Product Code
    21
    Applicant Total
    7
    Review Days
    25

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    Basic Information

    Device Name
    CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS
    K Number
    K903544
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    J.J. Skinner, Inc.
    Date Received
    August 6, 1990
    Decision Date
    August 31, 1990
    Product Code
    LRP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRP Tray, Surgical

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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
    K925469 JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT
    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