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 |