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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 K874364
Device Name BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
P.O.Box 450
Rochester,  NY  14692
Applicant Contact DAVIES, O.D.
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
P.O.Box 450
Rochester,  NY  14692
Correspondent Contact DAVIES, O.D.
Regulation Number886.5928
Classification Product Code
LPN  
Date Received10/23/1987
Decision Date 11/25/1987
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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