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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lens, contact (other material) - daily
510(k) Number K171404
Device Name BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
BAUSCH + LOMB Incorporated
1400 North Goodman Street
Rochester NY,  NY  14609
Applicant Contact Glenn A. Davies
Foresight Regulatory Strategies, Inc
187 Ballardvale Street, Suite A250
Wilmington,  MA  01887
Correspondent Contact Ellen M. Beucler
Regulation Number886.5916
Classification Product Code
Date Received05/12/2017
Decision Date 07/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No