LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980783
    Device Name
    SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5
    Manufacturer
    IRT MANAGEMENT CORP.
    Date Cleared
    1998-04-21

    (50 days)

    Product Code
    KHR
    Regulation Number
    872.6050
    Why did this record match?
    Product Code :

    KHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    General Usage: For the absorption/Collection and removal of excessive saliva during dental procedures. For the absorption/Collection and removal of saliva when excessive saliva is seen collecting in the mouth. For the absorption/Collection and removal of saliva in General Pediatric Use. For the absorption/Collection and removal of saliva whenever a potential choking hazard exists with commonly used saliva absorbers. For the absorption and removal of saliva when typical "suction" type devices are not appropriate or effective. ... For the collection of saliva when other absorber devices or suction devices are not appropriate or tolerated easily by the patient.
    Device Description
    SIMPLEX™ SALIVA ABSORBER/COLLECTOR
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1