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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHYDRASOFT (METHAFILCON B) CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Name(methafilcon a) contact lens
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP850079
Date Received10/30/1985
Decision Date01/31/1986
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 86M-0110
Notice Date 03/28/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S007 
S008 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 
S020 S021 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S034 
S036 S037 S038 S039 S040 S041 
S042 S043 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 
S055 S056 S057 S058 S059 S060 
S061 S062 S064 
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