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 |