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

    C-MASK

    K Number: K882882 · Decision Aug 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    C-MASK
    K Number
    K882882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Promedica Products, Inc.
    Date Received
    July 11, 1988
    Decision Date
    August 10, 1988
    Product Code
    FXX
    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
    FXX Mask, Surgical

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    Other Clearances by Promedica Products, Inc.

    K Number Device Name
    K913101 PETERS CARDIOFLON(TM) SUTURE
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    K883412 THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)
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