Creme de La Femme Feminine Lubricant— 510(k) K180014

Substantially Equivalent

Cewal, Inc. Dba Premiere Enterprises

FDA 510(k) clearance K180014 for Creme de La Femme Feminine Lubricant, Substantially Equivalent on 2018-12-21. Applicant: Cewal, Inc. Dba Premiere Enterprises.

Clearance details

Applicant
Cewal, Inc. Dba Premiere Enterprises
Product code
Code NUC
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Los Angeles, 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.