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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 K974723
Device Name RENU MULTIPLUS MULTI-PURPOSE SOLUTION
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact PAUL G STAPLETON
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact PAUL G STAPLETON
Regulation Number886.5928
Classification Product Code
LPN  
Date Received12/18/1997
Decision Date 03/10/1998
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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