The following data is part of a premarket notification filed by Noble Fiber Technologies, Inc. with the FDA for Silverseal Wound Packing Strips With X-static.
| Device ID | K063190 |
| 510k Number | K063190 |
| Device Name: | SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC |
| Classification | Dressing, Wound, Drug |
| Applicant | NOBLE FIBER TECHNOLOGIES, INC. 300 PALM ST. Scranton, PA 18505 |
| Contact | Patricia Davidson |
| Correspondent | Patricia Davidson NOBLE FIBER TECHNOLOGIES, INC. 300 PALM ST. Scranton, PA 18505 |
| 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 | 2006-10-20 |
| Decision Date | 2007-08-21 |
| Summary: | summary |