The following data is part of a premarket notification filed by River's Edge Pharmaceuticals, Llc with the FDA for Modification To Zenieva.
| Device ID | K083721 |
| 510k Number | K083721 |
| Device Name: | MODIFICATION TO ZENIEVA |
| Classification | Dressing, Wound, Hydrogel Without Drug And/or Biologic |
| Applicant | RIVER'S EDGE PHARMACEUTICALS, LLC 2445 SOUTH ALSTON AVE. Durham, NC 27713 |
| Contact | Sandra R Kircus |
| Correspondent | Sandra R Kircus RIVER'S EDGE PHARMACEUTICALS, LLC 2445 SOUTH ALSTON AVE. Durham, NC 27713 |
| Product Code | NAE |
| CFR Regulation Number | 878.4022 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-01-08 |
| Summary: | summary |