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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 K983894
Device Name BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609 -3547
Applicant Contact DENNIS HAHN
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609 -3547
Correspondent Contact DENNIS HAHN
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received11/03/1998
Decision Date 11/18/1998
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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