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

    JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY

    K Number: K961683 · Decision May 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    7
    Review Days
    9

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    Basic Information

    Device Name
    JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY
    K Number
    K961683
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J.J. Skinner, Inc.
    Date Received
    May 1, 1996
    Decision Date
    May 10, 1996
    Product Code
    LRO
    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
    LRO General Surgery 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
    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
    K903544 CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS