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

    KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD

    K Number: K902000 · Decision Aug 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    111

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    Basic Information

    Device Name
    KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD
    K Number
    K902000
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Kevtek Medical Products, Inc.
    Date Received
    May 2, 1990
    Decision Date
    August 21, 1990
    Product Code
    FZS
    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
    FZS Curette, Surgical, General Use

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    Other Clearances by Kevtek Medical Products, Inc.

    K Number Device Name
    K902193 KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP