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

    CENTRAL SUPPLY ROOM WRAP

    K Number: K823513 · Decision Jan 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    15
    Review Days
    39

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    Basic Information

    Device Name
    CENTRAL SUPPLY ROOM WRAP
    K Number
    K823513
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    James River Corp.
    Date Received
    November 29, 1982
    Decision Date
    January 7, 1983
    Product Code
    FRG
    Advisory Committee
    General Hospital
    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
    FRG Wrap, Sterilization

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    Other Clearances by James River Corp.

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    K883802 CARETEX CENTRAL SUPPLY WRAP
    K884112 CARETEX OR TOWEL
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