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

    PERI-COMFORT(TM) SEATING CUSHION

    K Number: K932396 · Decision Sep 30, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    135

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    Basic Information

    Device Name
    PERI-COMFORT(TM) SEATING CUSHION
    K Number
    K932396
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chi'Am Intl.
    Date Received
    May 18, 1993
    Decision Date
    September 30, 1993
    Product Code
    LRL
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LRL Cushion, Hemorrhoid

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