The following data is part of a premarket notification filed by Noble Fiber Technologies, Inc. with the FDA for Silverseal Contacting Wound Dressing With X-static.
| Device ID | K050649 |
| 510k Number | K050649 |
| Device Name: | SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC |
| Classification | Dressing, Wound, Drug |
| Applicant | NOBLE FIBER TECHNOLOGIES, INC. 421 SOUTH STATE ST. Clarks Summit, PA 18411 |
| Contact | William F Mcnally |
| Correspondent | William F Mcnally NOBLE FIBER TECHNOLOGIES, INC. 421 SOUTH 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 | 2005-03-14 |
| Decision Date | 2005-06-13 |
| Summary: | summary |