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.
Device ID | K143155 |
510k Number | K143155 |
Device Name: | LISTERINE Sensitivity Defense Mouthrinse |
Classification | Varnish, Cavity |
Applicant | Johnson & Johnson Healthcare Products, Division Of McNeil-PP 199 Grandview Road Skillman, NJ 08558 |
Contact | Angelina M. Hunt |
Correspondent | Angelina M. Hunt Johnson & Johnson Healthcare Products, Division Of McNeil-PP 199 Grandview Road Skillman, NJ 08558 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-03 |
Decision Date | 2015-01-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00312547235976 | K143155 | 000 |
00312547235969 | K143155 | 000 |
00312547235952 | K143155 | 000 |