The following data is part of a premarket notification filed by Adri with the FDA for Alginate Wool Fiber.
Device ID | K870383 |
510k Number | K870383 |
Device Name: | ALGINATE WOOL FIBER |
Classification | Absorber, Saliva, Paper |
Applicant | ADRI P.O. BOX 134 Park Forest, IL 60466 |
Contact | George H Scherr |
Correspondent | George H Scherr ADRI P.O. BOX 134 Park Forest, IL 60466 |
Product Code | KHR |
CFR Regulation Number | 872.6050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-30 |
Decision Date | 1987-04-30 |