The following data is part of a premarket notification filed by Noble Fiber Technologies with the FDA for X-static Silverseal Hydrocolloid Film And Island Dressing.
| Device ID | K033900 |
| 510k Number | K033900 |
| Device Name: | X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | NOBLE FIBER TECHNOLOGIES 421 S. STATE ST. Clarks Summit, PA 18411 |
| Contact | Patricia Davidson |
| Correspondent | Patricia Davidson NOBLE FIBER TECHNOLOGIES 421 S. STATE ST. Clarks Summit, PA 18411 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-12-17 |
| Decision Date | 2005-01-14 |
| Summary: | summary |