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

    CONVERTORS FLASH STERILIZING TRAY

    K Number: K832137 · Decision Aug 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    19
    Review Days
    42

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    Basic Information

    Device Name
    CONVERTORS FLASH STERILIZING TRAY
    K Number
    K832137
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Convertors Div., American Pharmaseal
    Date Received
    July 1, 1983
    Decision Date
    August 12, 1983
    Product Code
    FSM
    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
    FSM Tray, Surgical, Instrument

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    Other Clearances by American Convertors Div., American Pharmaseal

    K Number Device Name
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    K813419 COMFORT CUSHION DRY BURN PAD III
    K813296 CONVERTORS STERILE DISP. LAP SPONGE II
    K813078 CONTURA DISPOS. SURG. FACE MASK
    K812554 TOMAC STERILE DISP. LAP SPONGE
    K802919 ISO-BAC INSTRUMENT WRAP
    K802998 PATIENT CARE DISPOSABLE INFANT SHIRTS
    K802359 DISP. FENESTRATED SURG. DRAPE SHEETS
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