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

    SURGICAL INSTRUMENT KIT, DISPOSABLE

    K Number: K923175 · Decision Jun 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    21
    Review Days
    370

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    Basic Information

    Device Name
    SURGICAL INSTRUMENT KIT, DISPOSABLE
    K Number
    K923175
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ulti-Med Intl., Inc.
    Date Received
    June 12, 1992
    Decision Date
    June 17, 1993
    Product Code
    FMC
    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
    FMC Patient Examination Glove

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