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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K983225
Device Name BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER
Applicant
Bausch & Lomb, Inc.
1400 N Goodman St.
Rochester,  NY  14692
Applicant Contact YVONNE E MIDDLEFELL
Correspondent
Bausch & Lomb, Inc.
1400 N Goodman St.
Rochester,  NY  14692
Correspondent Contact YVONNE E MIDDLEFELL
Regulation Number886.5928
Classification Product Code
LPN  
Date Received09/14/1998
Decision Date 03/29/1999
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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