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

    DEROYAL SURGICAL DRAPES BACKTABLE COVER

    K Number: K030908 · Decision Aug 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    5
    Review Days
    140

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    Basic Information

    Device Name
    DEROYAL SURGICAL DRAPES BACKTABLE COVER
    K Number
    K030908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Deroyal
    Date Received
    March 24, 2003
    Decision Date
    August 11, 2003
    Product Code
    KKX
    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
    KKX Drape, Surgical, Antimicrobial

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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
    K031408 DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
    K020753 DEROYAL SURGICAL, UMBILICUP