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510(k) Data Aggregation

    K Number
    K983585
    Device Name
    LOW PH PHENOLIC 256
    Manufacturer
    CENTRAL SOLUTIONS, INC.
    Date Cleared
    1998-11-06

    (24 days)

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

    CENTRAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Is a general for repose as interfact For use in health care settings for low and intermediate level disinfection of hard, non-porsus, increase in the contra suffaces of wheelchairs, medical beds, patient transfer iffs, cruiches, instrument trays, operating tables, surfaces of Pricolonalic, modical paintal chairs, medical lamps, whilipool bathing units, and other medical devices that require low or internediate level disinfection. This product may be used to preclaan or decontaminate attical or non-citical medical devices prior to sterilization or high-loved disintedion. The effectiveness of this product has been documented at a temperature of 68°F (20°C), with a ten minute contact time on the surface being treated.
    Device Description
    Low pH Phenolic 256 is a liquid germicidal detergent formulated to clean, disinfect, and deodorize any washable, non-porous surface in one easy step. Low pH Phenolic 256 is recommended for use by hospitals, nursing homes, and other health care institutions that are dedicated to controlling cross-contamination in their establishments. Low pH Phenolic 256 is for use on any hard, inanimate surfaces such as door handles, medical bed surfaces, springs, wheelchairs, walls, floors, light switches, linen carts, stretcher wheels, toilet bowl surfaces, showers, bathtubs, bed frames, patient transfer lifts, patient scales, examination tables, dental chairs, stethoscopes, bedpans, blood donor chairs, and other hard, non-porous surfaces that need disinfection.
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    K Number
    K955850
    Device Name
    PRO-TECH
    Manufacturer
    CENTRAL SOLUTIONS, INC.
    Date Cleared
    1996-02-09

    (44 days)

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

    CENTRAL SOLUTIONS, INC.

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

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