The following data is part of a premarket notification filed by Dr. August Wolff Gmbh & Co. Kg Arzneimittel with the FDA for Vagisan Moistcream Cremolum.
| Device ID | K193444 |
| 510k Number | K193444 |
| Device Name: | Vagisan MoistCream Cremolum |
| Classification | Lubricant, Personal |
| Applicant | Dr. August Wolff GmbH & Co. KG Arzneimittel Sudbrackstrasse 56 Bielefeld, DE D-33611 |
| Contact | Thomas Flototto |
| Correspondent | Oliver Eikenberg Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-12 |
| Decision Date | 2020-12-04 |