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

    KLINIDRAPE SURGICAL DRAPES

    K Number: K000906 · Decision Jun 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    10
    Review Days
    94

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    Basic Information

    Device Name
    KLINIDRAPE SURGICAL DRAPES
    K Number
    K000906
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Molnlycke Health Care, Inc.
    Date Received
    March 21, 2000
    Decision Date
    June 23, 2000
    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 Molnlycke Health Care, Inc.

    K Number Device Name
    K062138 POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
    K051625 BARRIER SURGICAL DRAPES
    K000902 KLINIDRAPE REINFORCED SURGICAL GOWNS
    K000901 KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
    K984371 MEPITEL NON ADHERENT SILICONE DRESSING
    K984370 HYPERGEL 20% HYPERTONIC SALINE GEL
    K984368 NORMLGEL 0.9% ISOTONIC SALINE GEL
    K983554 ALLDRESS, ABSORBENT FILM DRESSING
    K983184 MEPILEX