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

    RICA OR SMIC SURGICAL INSTRUMENTS

    K Number: K801028 · Decision May 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    13
    Applicant Total
    6
    Review Days
    19

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    Basic Information

    Device Name
    RICA OR SMIC SURGICAL INSTRUMENTS
    K Number
    K801028
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Robert I. Chien & Assoc., Inc.
    Date Received
    May 1, 1980
    Decision Date
    May 20, 1980
    Product Code
    HXD
    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
    HXD Clamp

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    Other Clearances by Robert I. Chien & Assoc., Inc.

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    K811631 THERMOMETER (MADE IN CHINA)
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