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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 NameSAULFON PW-70 A&B
Classification Namelenses, soft contact, extended wear
Generic Namesoft lenses
Regulation Number886.5925
PMA NumberP840031
Date Received07/05/1984
Decision Date04/12/1985
Withdrawal Date 11/07/2007
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 85M-0224
Notice Date 06/19/1985
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 S004 S006 S007 S008 S009