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510(k) Data Aggregation
K Number
K990703Device Name
SPOROX II STERILIZING & DISINFECTING SOLUTION
Manufacturer
RECKITT BENCKISER, INC.
Date Cleared
1999-03-30
(26 days)
Product Code
MED
Regulation Number
880.6885Why 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
K970230Device Name
SPOROX
Manufacturer
RECKITT BENCKISER, INC.
Date Cleared
1997-10-29
(281 days)
Product Code
MED
Regulation Number
880.6885Why 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
K963353Device 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
880.6890Why 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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