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

    EMM EQUIPMENT COVER-POLYTHYLENE

    K Number: K101689 · Decision Sep 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    7
    Review Days
    96

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    Basic Information

    Device Name
    EMM EQUIPMENT COVER-POLYTHYLENE
    K Number
    K101689
    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
    June 16, 2010
    Decision Date
    September 20, 2010
    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
    K121919 SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
    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
    K101593 EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL