The following data is part of a premarket notification filed by Nivagen Pharmaceuticals Inc. with the FDA for Nivatopic Plus.
| Device ID | K132329 |
| 510k Number | K132329 |
| Device Name: | NIVATOPIC PLUS |
| Classification | Dressing, Wound, Drug |
| Applicant | NIVAGEN PHARMACEUTICALS INC. 248 LATITUDE LANE, STE 104 Lake Wylie, SC 29710 |
| Contact | Lara Noah |
| Correspondent | Lara Noah NIVAGEN PHARMACEUTICALS INC. 248 LATITUDE LANE, STE 104 Lake Wylie, SC 29710 |
| 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 | 2013-07-26 |
| Decision Date | 2013-12-20 |
| Summary: | summary |