BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS

    K Number: K080629 · Decision Oct 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    6
    Review Days
    229

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    Basic Information

    Device Name
    PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
    K Number
    K080629
    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
    Promedical Products Co., Ltd.
    Date Received
    March 5, 2008
    Decision Date
    October 20, 2008
    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 Promedical Products Co., Ltd.

    K Number Device Name
    K091097 PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
    K080627 PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
    K042111 PROMEDICAL SURGICAL GOWNS
    K042131 PROMEDICAL SURGICAL DRAPES
    K042137 PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS