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 |