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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.
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Toray Industries (America), Inc.
1-1-1 sonoyama
otsu-shi, shiga-ken 520 520
PMA NumberP840044
Date Received09/24/1984
Decision Date01/24/1986
Withdrawal Date 10/10/2007
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 86M-0054
Notice Date 03/05/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002