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

    C-SECTION, LABOR & DELIVERY TRAYS (PACKS)

    K Number: K932216 · Decision Apr 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    5
    Applicant Total
    29
    Review Days
    347

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    Basic Information

    Device Name
    C-SECTION, LABOR & DELIVERY TRAYS (PACKS)
    K Number
    K932216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Associated Medical Products Co.
    Date Received
    May 7, 1993
    Decision Date
    April 19, 1994
    Product Code
    MLS
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MLS Labor And Delivery Kit

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    Other Clearances by Associated Medical Products Co.

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    K932218 CARDIAC CATH OR ANGIOGRAPHIC TRAYS
    K932219 SUTURE SET OR LACERATION TRAYS (PACKS)
    K842983 AMPCO OPTHALMIC TRAY
    K843114 AMPCO PROCEDURE TRAYS / PACKS
    K823839 AMPCO KIDNEY DIALYSIS TRAY
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