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

    CLEANING AND ISOLATION ROOM KIT

    K Number: K760904 · Decision Dec 30, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    56
    Review Days
    65

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    Basic Information

    Device Name
    CLEANING AND ISOLATION ROOM KIT
    K Number
    K760904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Hospital Supply Corp.
    Date Received
    October 26, 1976
    Decision Date
    December 30, 1976
    Product Code
    FYC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FYC Gown, Isolation, Surgical

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    K822990 CONVERTORS PRIMARY WOUND DRESSING II
    K830343 CONTAINER W/PRIMING SOLUTION
    K830301 STRATUS FLUOROMETRIC ENZYME IMMUN0-
    K822755 LATEX PENROSE TUBING
    K823418 HEYER-SCHUTE UNIVERSAL URETERAL STENT
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