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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K143155
Device Name LISTERINE Sensitivity Defense Mouthrinse
Applicant
Johnson & Johnson Healthcare Products, Division of McNeil-PP
199 Grandview Road
Skillman,  NJ  08558
Applicant Contact ANGELINA M. HUNT
Correspondent
Johnson & Johnson Healthcare Products, Division of McNeil-PP
199 Grandview Road
Skillman,  NJ  08558
Correspondent Contact ANGELINA M. HUNT
Regulation Number872.3260
Classification Product Code
LBH  
Date Received11/03/2014
Decision Date 01/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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