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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSOFLOW PW (LIDOFILCON B)
Classification Namelenses, soft contact, extended wear
Generic Namesoft contact lenses
Regulation Number886.5925
ApplicantHEYER SCHULTE CORP.
PMA NumberP790020
Supplement NumberS001
Date Received05/02/1980
Decision Date06/16/1981
Product Code
LPM[ Registered Establishments with LPM ]
Notice Date 03/04/1981
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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