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

    MICROTEK MEDICAL'S SOUND STIKS

    K Number: K913276 · Decision Oct 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    13
    Review Days
    90

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    Basic Information

    Device Name
    MICROTEK MEDICAL'S SOUND STIKS
    K Number
    K913276
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microbio-Medics, Inc.
    Date Received
    July 23, 1991
    Decision Date
    October 21, 1991
    Product Code
    EWO
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EWO Audiometer

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    Other Clearances by Microbio-Medics, Inc.

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    K910167 MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM
    K900726 MICROTEK MEDICAL'S BLOOD COLLECTION KIT
    K901154 MICROTEK'S SURGICAL LAMP HANDLE & COVER
    K895815 MICROTEK TOTAL OSSICULAR PROTHESIS
    K895814 MICROTEK PISTON & WIRE PROSTHESES
    K895502 MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
    K885201 OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT
    Search all 13 clearances from Microbio-Medics, Inc. →