The following data is part of a premarket notification filed by Isdin Corp with the FDA for Nutraseb Facial Cream.
| Device ID | K143605 |
| 510k Number | K143605 |
| Device Name: | Nutraseb Facial Cream |
| Classification | Dressing, Wound, Drug |
| Applicant | ISDIN Corp 100 Overlook Center 2nd Floor Princeton, NJ 08540 |
| Contact | Steve Smith |
| Correspondent | Karen Kopicko ISDIN Corp 100 Overlook Center 2nd Floor Princeton, NJ 08540 |
| 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 | 2014-12-19 |
| Decision Date | 2016-04-14 |
| Summary: | summary |