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

    STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G

    K Number: K991612 · Decision May 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    2
    Review Days
    18

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    Basic Information

    Device Name
    STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
    K Number
    K991612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterilogic Waste Systems, Inc.
    Date Received
    May 10, 1999
    Decision Date
    May 28, 1999
    Product Code
    MMK
    Advisory Committee
    General Hospital
    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
    MMK Container, Sharps

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    Other Clearances by Sterilogic Waste Systems, Inc.

    K Number Device Name
    K020664 STERISHARP 3-GALLON RSDC, MODEL RSDC3G