The following data is part of a premarket notification filed by Adri/technam with the FDA for Alginate Fiber.
| Device ID | K914779 |
| 510k Number | K914779 |
| Device Name: | ALGINATE FIBER |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | ADRI/TECHNAM P.O. BOX 134 Park Forest, IL 60466 |
| Contact | George H Scherr |
| Correspondent | George H Scherr ADRI/TECHNAM P.O. BOX 134 Park Forest, IL 60466 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-23 |
| Decision Date | 1991-12-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ALGINATE FIBER 85436886 not registered Dead/Abandoned |
GHP Biotec, LLC 2011-09-30 |