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

    MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL

    K Number: K811087 · Decision May 1, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    10
    Review Days
    10

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    Basic Information

    Device Name
    MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL
    K Number
    K811087
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Cunningham Woodland, Inc.
    Date Received
    April 21, 1981
    Decision Date
    May 1, 1981
    Product Code
    FSM
    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
    FSM Tray, Surgical, Instrument

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    Other Clearances by Cunningham Woodland, Inc.

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    K811090 MAJOR DRESSING TRAY
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    K811086 SUTURE REMOVAL SET(DISPLSABLE)