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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.
 
DeviceH55 HYDROPHILIC CONTACT LENS
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantTHE COOPER COMPANIES
6150 stoneridge mall road
suite 370
pleasanton, CA 94588
PMA NumberP890023
Date Received04/03/1989
Decision Date09/19/1989
Product Code LPM 
Docket Number 89M-0472
Notice Date 11/27/1989
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S042 S043 S044 S045 S046 S047 S048 S049 
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