BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PRESSURE IRRIGATING SYSTEM

    K Number: K936223 · Decision May 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    95
    Applicant Total
    5
    Review Days
    134

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    Basic Information

    Device Name
    PRESSURE IRRIGATING SYSTEM
    K Number
    K936223
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Level 1 Technologies, Inc.
    Date Received
    December 29, 1993
    Decision Date
    May 12, 1994
    Product Code
    GCY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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