Bloomi Delight Oil-Based Personal Lubricant— 510(k) K222175
Substantially EquivalentThe Bloomi Inc..
FDA 510(k) clearance K222175 for Bloomi Delight Oil-Based Personal Lubricant, Substantially Equivalent on 2022-11-15. Applicant: The Bloomi Inc...
Clearance details
- Applicant
- The Bloomi Inc..
- Product code
- Code NUC
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alamo, CA, US
Adverse events under product code NUC
product code NUC- Other
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.