The following data is part of a premarket notification filed by Colgate-palmolive Company with the FDA for Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-relief Mouthwash.
Device ID | K140481 |
510k Number | K140481 |
Device Name: | COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH |
Classification | Varnish, Cavity |
Applicant | COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD Piscataway, NJ 08855 -1343 |
Contact | Charles Ireland |
Correspondent | Charles Ireland COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD Piscataway, NJ 08855 -1343 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-26 |
Decision Date | 2014-06-05 |
Summary: | summary |