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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratome, ac-powered
510(k) Number K062465
Device Name ZYOPTIX XP EPI SEPARATOR SYSTEM
Applicant
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER,  NY  14609 -3547
Applicant Contact NED LUCE
Correspondent
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER,  NY  14609 -3547
Correspondent Contact NED LUCE
Regulation Number886.4370
Classification Product Code
HNO  
Date Received08/24/2006
Decision Date 09/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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