Clearance Summary
Dr. Wolff Vagisan Moisturising Cream received FDA 510(k) clearance under submission number K152507, sponsored by Dr. August Wolff GmbH & Co. KG Arzeimittel. 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 2016-05-20.
- Submission: K152507
- Applicant / Sponsor: Dr. August Wolff GmbH & Co. KG Arzeimittel
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2016-05-20
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.