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510(k) Data Aggregation

    K Number
    K990703
    Device Name
    SPOROX II STERILIZING & DISINFECTING SOLUTION
    Manufacturer
    RECKITT BENCKISER, INC.
    Date Cleared
    1999-03-30

    (26 days)

    Product Code
    MED
    Regulation Number
    880.6885
    Why did this record match?
    Applicant Name (Manufacturer) :

    RECKITT BENCKISER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SPOROX® II has the same intended use as SPOROX®. SPOROX® II is intended to be used as a ready-to-use liquid chemical sterilant for the sterilization or high level disinfection of heat sensitive medical equipment for which alternative methods of terminal reprocessing are not suitable or available. SPOROX® II Sterilizing & Disinfecting Solution is a ready to use liquid chemical germicide. The product is a 7.5% nominal hydrogen peroxide solution buffered with phosphoric acid. The minimum effective concentration (MEC) is 6%. SPOROX II ® Sterilizing & Disinfecting Solution is intended for use in the high level disinfection of heat sensitive medical equipment using the prescribed contact conditions. Devices must be soaked for 30 minutes at 20℃ to high level disinfect. SPOROX II® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.
    Device Description
    SPOROX® II is a nominal 7.5% hydrogen peroxide solution, buffered with phosphoric acid. Hydrogen peroxide, the active ingredient in SPOROX® II, exerts its germicide via a strong oxidation reaction with cellular components.
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    K Number
    K970230
    Device Name
    SPOROX
    Manufacturer
    RECKITT BENCKISER, INC.
    Date Cleared
    1997-10-29

    (281 days)

    Product Code
    MED
    Regulation Number
    880.6885
    Why did this record match?
    Applicant Name (Manufacturer) :

    RECKITT BENCKISER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sporox® Sterilizing & Disinfecting Solution is a ready-to-use liquid chemical germicide. The product is a 7.5% nominal hydrogen peroxide solution buffered with phosphoric acid. The minimum effective concentration (MEC) is 6%. Sporox® Sterilizing and Disinfecting Solution is intended for use in the high level disinfection of heat sensitive medical equipment using the prescribed contact conditions. Devices must be soaked for 30 minutes at 20℃ to high level disinfect. Sporox® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.
    Device Description
    Sporox is a nominal 7.5% hydrogen peroxide solution, buffered with phosphoric acid. Hydrogen peroxide, the active ingredient in Sporox, ® exerts i s germicide via a strong oxidation reaction of cellular components.
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    K Number
    K963353
    Device Name
    LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)
    Manufacturer
    RECKITT BENCKISER, INC.
    Date Cleared
    1996-10-18

    (53 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Why did this record match?
    Applicant Name (Manufacturer) :

    RECKITT BENCKISER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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