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

    DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)

    K Number: K031408 · Decision Oct 15, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    5
    Review Days
    163

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    Basic Information

    Device Name
    DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
    K Number
    K031408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Deroyal
    Date Received
    May 5, 2003
    Decision Date
    October 15, 2003
    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 Deroyal

    K Number Device Name
    K041416 EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER
    K033057 DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
    K030908 DEROYAL SURGICAL DRAPES BACKTABLE COVER
    K020753 DEROYAL SURGICAL, UMBILICUP