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510(k) Data Aggregation
K Number
K991620Device Name
VISINE FOR CONTACTS
Manufacturer
Date Cleared
1999-09-24
(136 days)
Product Code
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
PFIZER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
VISINE FOR CONTACTS Rewetting Drops may be used with daily and extended wear soft (hydrophilic) contact lenses for the following:
- Moistening of daily wear soft lenses while on the eyes during the day
- Moistening of extended wear soft lenses upon awakening and as needed during the day
- Moistening of extended wear soft lenses prior to retiring at night
Placing 1 or 2 drops of VISINE FOR CONTACTS Rewetting Drops on the eye followed by blinking 2 or 3 times will relieve minor irritation, discomfort and blurring which may occur while wearing lenses.
Device Description
Visine for Contacts is specially formulated to use while wearing contact lenses to moisten lenses, soothe, refresh and moisturize dry, irritated eyes. Visine for Contacts is safe and effective for individuals with eyes sensitive to thimerosal. It moistens lenses and helps remove particulate matter that may cause irritation and/or discomfort.
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