The following data is part of a premarket notification filed by Natureplex, Llc with the FDA for Natureplex Warm Touch Warming Jelly.
| Device ID | K180828 |
| 510k Number | K180828 |
| Device Name: | Natureplex Warm Touch Warming Jelly |
| Classification | Lubricant, Personal |
| Applicant | Natureplex, LLC 11085 Airport Road Olive Branch, MS 38654 |
| Contact | Pamela Hopkins |
| Correspondent | Pamela Hopkins Natureplex, LLC 11085 Airport Road Olive Branch, MS 38654 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-12-20 |
| Summary: | summary |