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510(k) Data Aggregation
K Number
K210051Device Name
OTE MPS 045 Multi-purpose Lens Care Solution
Manufacturer
OTE North America LLC
Date Cleared
2021-05-26
(138 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
OTE North America LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTE MPS 045 Multi-Purpose Lens Care Solution is indicated for daily cleaning, chemical (not heat) disinfection, conditioning, rinsing and storage of hydrogel and silicone hydrogel soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Device Description
OTE MPS 045 Multi-Purpose Lens Care Solution is a sterile, buffered aqueous solution that contains sodium hyaluronate, poloxamer 407, boric acid, sodium borate, propylene glycol, and is preserved with Polyaminopropyl Biguanide Hydrochloride 0.00002%, Polyquaternium-2 0.00043%, and edetate disodium.
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