The following data is part of a premarket notification filed by Neo Cosmetique with the FDA for Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry.
| Device ID | K163674 |
| 510k Number | K163674 |
| Device Name: | Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry |
| Classification | Lubricant, Personal |
| Applicant | NEO COSMETIQUE 15 RUE MONTJOIE Saint Denis, FR 93212 |
| Contact | Nathalie Vernin |
| Correspondent | Gayle Lyne TECHNIC INC 47 MOLTER AVE Cranston, RI 02910 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-27 |
| Decision Date | 2017-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701411600021 | K163674 | 000 |
| 03701411600014 | K163674 | 000 |