The following data is part of a premarket notification filed by Xr Llc with the FDA for Passion Natural Water Based Lubricant.
| Device ID | K202017 |
| 510k Number | K202017 |
| Device Name: | Passion Natural Water Based Lubricant |
| Classification | Lubricant, Personal |
| Applicant | XR LLC 5251 Pipeline Lane Huntington Beach, CA 92649 |
| 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 | 2020-07-21 |
| Decision Date | 2021-01-08 |