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510(k) Data Aggregation
K Number
K112832Device Name
EYE CARE CURE CONTACT LENS CASE
Manufacturer
EYE CARE AND CURE
Date Cleared
2011-12-05
(67 days)
Product Code
LRX
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
EYE CARE AND CURE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The storage and disinfection of soft, rigid gas permeable or hard contact lenses. For use during chemical disinfection only. Not to be used with heat.
Device Description
The Eye Care and Cure Contact Lens Case consists of a lens case base with adjoining dual walls for the containment of fluid and separate integral hinged self-sealing caps. The Eye Care and Cure Contact Lens Case is polyethylene and consists of a two adjoining wells, with hinged self-sealing caps, in which contact lenses are immersed in fluid. The two adjoining wells of the Eye Care and Cure Contact Lens Case each have a capacity of 1.0ml. The inner height of the well measures 8mm. The Eye Care and Cure Contact Lens Case is made of Dow Chemical Company Low Density Polyethylene, Dow Product #9931. No colorant will be added.
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