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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 K013232
Device Name CYBERCASES BY BAUSCH & LOMB
Applicant
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
P.O. BOX 30450
ROCHESTER,  NY  14609
Applicant Contact KIM S DEVITTO
Correspondent
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
P.O. BOX 30450
ROCHESTER,  NY  14609
Correspondent Contact KIM S DEVITTO
Regulation Number886.5928
Classification Product Code
LRX  
Date Received09/27/2001
Decision Date 11/20/2001
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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