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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 NameSOFT-55 EW APHAKIC (VIFILCON A) SOFT(HYDROPHILIC) SPHERICAL CONTACT LENS FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantUNILENS CORP., USA
PMA NumberP960039
Supplement NumberS002
Date Received01/29/2001
Decision Date01/03/2002
Product Code
LPM[ Registered Establishments with LPM ]
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 the manufacturing facility located at unilens corporation, usa, largo, florida.
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