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

    UNSTERILIZED LAPAROTOMY SPONGES (CHINA)

    K Number: K811632 · Decision Sep 11, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    6
    Review Days
    94

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    Basic Information

    Device Name
    UNSTERILIZED LAPAROTOMY SPONGES (CHINA)
    K Number
    K811632
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Robert I. Chien & Assoc., Inc.
    Date Received
    June 9, 1981
    Decision Date
    September 11, 1981
    Product Code
    GDY
    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
    GDY Gauze/Sponge, Internal, X-Ray Detectable

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

    K Number Device Name
    K822151 SURGICAL INSTRUMENTS REPRESENT. 4 CLASS
    K811631 THERMOMETER (MADE IN CHINA)
    K810054 RICA (DIAGNOSTIC INSTRUMENTS)
    K801819 SURGICAL INSTRUMENTS
    K801028 RICA OR SMIC SURGICAL INSTRUMENTS