The following data is part of a premarket notification filed by Adri/technam with the FDA for Alginate Fiber.
Device ID | K941176 |
510k Number | K941176 |
Device Name: | ALGINATE FIBER |
Classification | Bandage, Liquid |
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 | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-14 |
Decision Date | 1994-07-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ALGINATE FIBER 85436886 not registered Dead/Abandoned |
GHP Biotec, LLC 2011-09-30 |