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

    ROTECNO 2000 SURGICAL GOWN

    K Number: K982059 · Decision Nov 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    4
    Review Days
    172

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    Basic Information

    Device Name
    ROTECNO 2000 SURGICAL GOWN
    K Number
    K982059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Encompass Group, LLC
    Date Received
    June 11, 1998
    Decision Date
    November 30, 1998
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Encompass Group, LLC

    K Number Device Name
    K203085 NOVA Patient Warming System
    K982058 ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
    K760618 PATIENT RESTRAINT