BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STERILE DISPOSABLE DRAPE(S)

    K Number: K910468 · Decision Mar 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    21
    Review Days
    45

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    Basic Information

    Device Name
    STERILE DISPOSABLE DRAPE(S)
    K Number
    K910468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    E.M. Adams
    Date Received
    February 4, 1991
    Decision Date
    March 21, 1991
    Product Code
    FZI
    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
    FZI Apparatus, Air Handling, Enclosure

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    Other Clearances by E.M. Adams

    K Number Device Name
    K905173 SPLASH GUARD
    K873978 DISPOSABLE BIPOLAR FORCEPS
    K850063 INSTRUMENT POCKET
    K843724 I.V. START KIT & OBSTETRICAL KIT
    K843783 WET PACK
    K843782 DRY TRAY
    K843723 STERILE INSTRUMENT TRAYS-VARIOUS
    K843115 STERILE SOLUTION BOWL
    K843116 DISPOSABLE SKIN MARKING PEN
    K831841 STERILE DISP. INSTRUMENT TRAYS
    Search all 21 clearances from E.M. Adams →