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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Generic NameLens, contact (rigid gas permeable), extended wear
Regulation Number886.5916
ApplicantBAUSCH & LOMB
1400 N. GOODMAN ST.
ROCHESTER, NY 14692
PMA NumberP860022
Date Received06/02/1986
Decision Date11/30/1987
Product Code MWL 
Docket Number 87M-0395
Notice Date 01/19/1988
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
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 S059 
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