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510(k) Data Aggregation
K Number
K030910Device Name
CLUED UP MULTIPURPOSE SOLUTION- NO RUB
Manufacturer
Date Cleared
2003-10-10
(200 days)
Product Code
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
CLUED UP LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clued Up Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses, as recommended by the eye care practitioner
Device Description
Clued Up Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorohexidine or thimerosal.
Clued Up Multipurpose Solution remains unchanged from the previously approved product in K980147, except for the revised directions for use.
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