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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 K000247
Device Name BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact YVONNE MIDDLEFELL
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact YVONNE MIDDLEFELL
Regulation Number886.5928
Classification Product Code
LPN  
Date Received01/27/2000
Decision Date 04/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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