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

    PROMEDICAL SURGICAL GOWNS

    K Number: K042111 · Decision Dec 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    6
    Review Days
    127

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    Basic Information

    Device Name
    PROMEDICAL SURGICAL GOWNS
    K Number
    K042111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Promedical Products Co., Ltd.
    Date Received
    August 5, 2004
    Decision Date
    December 10, 2004
    Product Code
    FYA
    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
    FYA Gown, Surgical

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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
    K080629 PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
    K080627 PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
    K042131 PROMEDICAL SURGICAL DRAPES
    K042137 PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS