ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER— 510(k) K112217

Name: FDA 510(k) clearance K112217
Creator: U.S. Food and Drug Administration
Published: 2012-10-16

Substantially Equivalent

Polichem S.A

FDA 510(k) clearance K112217 for ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER, Substantially Equivalent on 2012-10-16. Applicant: Polichem S.A. Device class: 2.

Clearance details

Applicant: Polichem S.A
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2011-08-02
Decision date: 2012-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jackson, WI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.