The following data is part of a premarket notification filed by Reoxcyn, Llc with the FDA for Bunny Wax Personal Lubricant.
| Device ID | K192779 |
| 510k Number | K192779 |
| Device Name: | Bunny Wax Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | Reoxcyn, LLC 1488 West Pleasant View Drive, Sutie 150 Pleasant Grove, UT 84062 |
| Contact | Ellie Hartz |
| Correspondent | Ryan M Fournier Morgan, Lewis & Bockius LLP 1111 Pennsylvania Ave, NW Washington, DC 20004 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-06-02 |