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

    POLY-LINED TOWEL/DRAPE LINE

    K Number: K850199 · Decision Feb 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    5
    Review Days
    34

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    Basic Information

    Device Name
    POLY-LINED TOWEL/DRAPE LINE
    K Number
    K850199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Excel Health Care Products
    Date Received
    January 18, 1985
    Decision Date
    February 21, 1985
    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 Excel Health Care Products

    K Number Device Name
    K850960 NON-ABSORBENT DRAPES & ABSORBENT TOWELS
    K850456 TRACHEOSTOMY CARE KIT
    K850326 STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH
    K850325 STERILE SUTURE REMOVAL KIT