The following data is part of a premarket notification filed by Valencia Naturals Inc. with the FDA for Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant,.
| Device ID | K192204 |
| 510k Number | K192204 |
| Device Name: | Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, |
| Classification | Lubricant, Personal |
| Applicant | Valencia Naturals Inc. 9731 Topanga Canyon PL. Chatsworth, CA 91311 |
| Contact | Louie Goryoka |
| Correspondent | Louie Goryoka Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-14 |
| Decision Date | 2019-11-19 |
| Summary: | summary |