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

    MITEK STERILIZATION TRAY

    K Number: K893886 · Decision Aug 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    31
    Review Days
    83

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    Basic Information

    Device Name
    MITEK STERILIZATION TRAY
    K Number
    K893886
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mitek Surgical Products, Inc.
    Date Received
    May 30, 1989
    Decision Date
    August 21, 1989
    Product Code
    FLE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLE Sterilizer, Steam

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    Other Clearances by Mitek Surgical Products, Inc.

    K Number Device Name
    K953560 MITEK THREADED ANCHOR (FASTIN)
    K953877 MITEK GII ANCHOR
    K936311 MITEK MINI ANCHOR
    K941599 MITEK ABSORBABLE ANCHOR
    K944051 ABSORBALBE ANCHOR
    K950070 MITEK TOGGLE ANCHOR(TM)
    K944936 MITEK G III ANCHOR, MITEK LS ANCHOR
    K945203 MITEK THRADED ANCHOR (MTA)
    K934366 MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
    K931782 MITEK GIII ANCHOR
    Search all 31 clearances from Mitek Surgical Products, Inc. →