The following data is part of a premarket notification filed by Dr. August Wolff Gmbh & Co. Kg Arzeimittel with the FDA for Dr. Wolff Vagisan Moisturising Cream.
| Device ID | K152507 |
| 510k Number | K152507 |
| Device Name: | Dr. Wolff Vagisan Moisturising Cream |
| Classification | Lubricant, Personal |
| Applicant | DR. AUGUST WOLFF GMBH & CO. KG ARZEIMITTEL SUDBRACKSTR. 56 Bielefeld, DE 33611 |
| Contact | Thomas Floetotto |
| Correspondent | Alan Curtis AEC MEDICAL DEVICE CONSULTING LLC 8300 E. DIXILETA DRIVE 285 Scottsdale, AZ 85266 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-02 |
| Decision Date | 2016-05-20 |
| Summary: | summary |