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

    STERILE LACERATION TRAY

    K Number: K890071 · Decision Jan 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    285
    Registration Numbers
    286
    Same Product Code
    21
    Applicant Total
    7
    Review Days
    15

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    Basic Information

    Device Name
    STERILE LACERATION TRAY
    K Number
    K890071
    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
    January 9, 1989
    Decision Date
    January 24, 1989
    Product Code
    LRP
    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
    LRP Tray, Surgical

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    Other Clearances by Mumtaz I. Malik

    K Number Device Name
    K901521 OSTEOTOMES OF VARIOUS TYPES
    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
    K884195 GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)