LISTERINE Sensitivity Defense Mouthrinse

Varnish, Cavity

Johnson & Johnson Healthcare Products, Division Of McNeil-PP

The following data is part of a premarket notification filed by Johnson & Johnson Healthcare Products, Division Of Mcneil-pp with the FDA for Listerine Sensitivity Defense Mouthrinse.

Pre-market Notification Details

Device IDK143155
510k NumberK143155
Device Name:LISTERINE Sensitivity Defense Mouthrinse
ClassificationVarnish, Cavity
Applicant Johnson & Johnson Healthcare Products, Division Of McNeil-PP 199 Grandview Road Skillman,  NJ  08558
ContactAngelina M. Hunt
CorrespondentAngelina M. Hunt
Johnson & Johnson Healthcare Products, Division Of McNeil-PP 199 Grandview Road Skillman,  NJ  08558
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-03
Decision Date2015-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00312547235976 K143155 000
00312547235969 K143155 000
00312547235952 K143155 000

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