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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K994335
Device Name PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
Applicant
Wesley Jessen Corp.
333 E. Howard Ave.
Des Plaines,  IL  60018
Applicant Contact JOSEPH F FOOS
Correspondent
Wesley Jessen Corp.
333 E. Howard Ave.
Des Plaines,  IL  60018
Correspondent Contact JOSEPH F FOOS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/23/1999
Decision Date 03/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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