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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.
 
DeviceOCUSIL(TM) CONTACT LENS
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantO.S.I. CORP.
601 GATEWAY BLVD.,#1050,
SOUTH SAN FRANCISCO, CA 94080-0000
PMA NumberP840050
Date Received10/09/1984
Decision Date11/20/1985
Reclassified Date 03/04/1994
Product Code HQD 
Docket Number 85M-0558
Notice Date 01/02/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S005 S006 S008 S009 S010 S011 S012 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 S041 S042 S043 S044 S045 S046 S047 S048 
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