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510(k) Data Aggregation
K Number
K974485Device Name
SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION
Manufacturer
SZABOCSIK AND ASSOC.
Date Cleared
1998-02-24
(90 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
SZABOCSIK AND ASSOC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution is indicated for use in chemical (not heat) disinfection, daily cleaning, rinsing and storage of daily and extended wear soft contact lenses as recommended by the eye care practitioner.
Device Description
A sterile, isotonic solution that contains Poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorhexidine or thimerosal. Cleans, loosens and removes accumulations of films, deposits and debris from soft contact lenses. Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewets lenses before the lenses are placed on the eye.
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