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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K896685
Device Name BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
P.O.Box 450
Rochester,  NY  14692
Applicant Contact DARLA J ELKIN
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
P.O.Box 450
Rochester,  NY  14692
Correspondent Contact DARLA J ELKIN
Regulation Number886.5928
Classification Product Code
LRX  
Date Received11/28/1989
Decision Date 12/26/1989
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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