Vagisan MoistCream Cremolum— 510(k) K193444

Name: FDA 510(k) clearance K193444
Creator: U.S. Food and Drug Administration
Published: 2020-12-04

Substantially Equivalent

Dr. August Wolff GmbH & Co. KG Arzneimittel

FDA 510(k) clearance K193444 for Vagisan MoistCream Cremolum, Substantially Equivalent on 2020-12-04. Applicant: Dr. August Wolff GmbH & Co. KG Arzneimittel. Device class: 2.

Clearance details

Applicant: Dr. August Wolff GmbH & Co. KG Arzneimittel
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2019-12-12
Decision date: 2020-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bielefeld, DE

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.