The following data is part of a premarket notification filed by United Consortium with the FDA for Jo Actively Trying Personal Lubricant.
Device ID | K182585 |
510k Number | K182585 |
Device Name: | JO Actively Trying Personal Lubricant |
Classification | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
Applicant | United Consortium 29000 N. Hancock Pkwy. Valencia, CA 91355 |
Contact | Stephanie Morris |
Correspondent | Stephanie Morris United Consortium 29000 N. Hancock Pkwy. Valencia, CA 91355 |
Product Code | PEB |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-20 |
Decision Date | 2019-04-26 |