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

    SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5

    K Number: K980783 · Decision Apr 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    50

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    Basic Information

    Device Name
    SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5
    K Number
    K980783
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6050
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Irt Management Corp.
    Date Received
    March 2, 1998
    Decision Date
    April 21, 1998
    Product Code
    KHR
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHR Absorber, Saliva, Paper

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