The following data is part of a premarket notification filed by Noble Fiber Technologies, Inc. with the FDA for Silverseal Silveraid With X-static.
Device ID | K050726 |
510k Number | K050726 |
Device Name: | SILVERSEAL SILVERAID WITH X-STATIC |
Classification | Dressing, Wound, Drug |
Applicant | NOBLE FIBER TECHNOLOGIES, INC. 421 SOUTH STATE ST. Clarks Summit, PA 18411 |
Contact | Patricia Davidson |
Correspondent | Patricia Davidson 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 | 2005-03-18 |
Decision Date | 2005-12-05 |
Summary: | summary |