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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 NamePERMALENS (PERFILCON) HYDROPHILIC CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namefor vision improvement use in wearers who are ap
Regulation Number886.5925
ApplicantCOOPER LABORATORIES
PMA NumberP780010
Supplement NumberS008
Date Received12/29/1980
Decision Date01/29/1981
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
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