The following data is part of a premarket notification filed by Exeltis Usa Dermatology, Llc with the FDA for Neocera Advanced Barrier Cream.
| Device ID | K170911 |
| 510k Number | K170911 |
| Device Name: | NEOCERA Advanced Barrier Cream |
| Classification | Dressing, Wound, Drug |
| Applicant | EXELTIS USA Dermatology, LLC 180 Park Avenue, Suite 101 Florham Park, NJ 07932 |
| Contact | Babu Lad |
| Correspondent | Babu Lad EXELTIS USA Dermatology, LLC 180 Park Avenue, Suite 101 Florham Park, NJ 07932 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-28 |
| Decision Date | 2017-08-22 |
| Summary: | summary |