The following data is part of a premarket notification filed by The Bloomi Inc.. with the FDA for Bloomi Smooth Water Based Lubricant.
| Device ID | K221328 |
| 510k Number | K221328 |
| Device Name: | Bloomi Smooth Water Based Lubricant |
| Classification | Lubricant, Personal |
| Applicant | The Bloomi Inc.. 74 Royal Ridge Court Alamo, CA 94507 |
| Contact | Rebecca Story |
| 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 | 2022-05-06 |
| Decision Date | 2022-08-04 |