Clearance Summary
Vagisan MoistCream Cremolum received FDA 510(k) clearance under submission number K193444, sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2020-12-04.
- Submission: K193444
- Applicant / Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2020-12-04
Classification & Regulation
This clearance is catalogued under FDA product code NUC and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.