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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.
 
Trade NameBIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
Classification Namelenses, soft contact, daily wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantCAL BIONICS
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.
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