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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 NameBOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Classification Namelens,contact(rigid gas permeable)-extended wear
Regulation Number886.5916
ApplicantPOLYMER TECHNOLOGY CORP.
PMA NumberP860022
Date Received06/02/1986
Decision Date11/30/1987
Product Code
MWL[ Registered Establishments with MWL ]
Docket Number 87M-0395
Notice Date 01/19/1988
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S043 S044 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 
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