Solevy Co. LLC Water-Based Personal Lubricant— 510(k) K203654

Substantially Equivalent

Solevy Co., LLC

FDA 510(k) clearance K203654 for Solevy Co. LLC Water-Based Personal Lubricant, Substantially Equivalent on 2021-04-19. Applicant: Solevy Co., LLC.

Clearance details

Applicant
Solevy Co., LLC
Product code
Code NUC
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Valencia, CA, US
Download summary PDFView on FDA.gov ↗

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.