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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namelenses, soft contact, daily wear
Generic Namecontact lenses
Regulation Number886.5925
PMA NumberP860040
Supplement NumberS013
Date Received02/28/1995
Decision Date11/27/1995
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for relocation of the alternate manufacturer, westcon contact lens co. , from 2775 crossroads boulevard, #110, grand junction, co 81506 to 611 eisenhauer street, grand junction, co 81505 and for a change in the sterilization process to include parametric release at westcon contact lens co. , 611 eisenhauer street, grand junction, co 81505 for horizon 55 spherical and horizon 55 toric (methafilcon a) hydrophilic contact lenses for extended wear.