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

    GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)

    K Number: K884195 · Decision Oct 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    103
    Applicant Total
    7
    Review Days
    18

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    Basic Information

    Device Name
    GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)
    K Number
    K884195
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Mumtaz I. Malik
    Date Received
    October 6, 1988
    Decision Date
    October 24, 1988
    Product Code
    GEN
    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
    GEN Forceps, General & Plastic Surgery

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    K901289 RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS
    K901511 CHISEL, BONE, SURGICAL
    K901420 VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8
    K893902 4 X 4 STERILE GAUZE SPONGE TRAY
    K890071 STERILE LACERATION TRAY