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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 NameHYDRASOFT (METHAFILCON A) CONTACT LENS
Classification Namelenses, soft contact, daily wear
Regulation Number886.5925
ApplicantCOAST CONTACT LENS, INC.
PMA NumberP850079
Supplement NumberS002
Date Received07/18/1986
Decision Date11/12/1986
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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