The following data is part of a premarket notification filed by Beeken Biomedical with the FDA for Nustat, Nustat Xr.
| Device ID | K142363 |
| 510k Number | K142363 |
| Device Name: | NUSTAT, NUSTAT XR |
| Classification | Dressing, Wound, Drug |
| Applicant | Beeken Biomedical 127 West Hargett Street, Suite 300 Raleigh, NC 27601 |
| Contact | Richard Kendall |
| Correspondent | Richard Kendall Beeken Biomedical 127 West Hargett Street, Suite 300 Raleigh, NC 27601 |
| 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 | 2014-08-25 |
| Decision Date | 2015-01-09 |
| Summary: | summary |