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

    SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV

    K Number: K121919 · Decision Feb 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    7
    Review Days
    227

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    Basic Information

    Device Name
    SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
    K Number
    K121919
    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
    Exact Medical Manufacturing, Inc.
    Date Received
    July 2, 2012
    Decision Date
    February 14, 2013
    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 Exact Medical Manufacturing, Inc.

    K Number Device Name
    K120045 EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
    K111535 EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
    K101598 EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)
    K101688 EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
    K101689 EMM EQUIPMENT COVER-POLYTHYLENE
    K101593 EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL