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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 K974780
Device Name SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact MICHAEL A SANTALUCIA
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact MICHAEL A SANTALUCIA
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/22/1997
Decision Date 03/11/1998
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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