The following data is part of a premarket notification filed by Analytichem International, Inc. with the FDA for Extube.
| Device ID | K781728 |
| 510k Number | K781728 |
| Device Name: | EXTUBE |
| Classification | Resins, Ion-exchange |
| Applicant | ANALYTICHEM INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KEA |
| CFR Regulation Number | 862.2230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-06 |
| Decision Date | 1978-12-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EXTUBE 77365703 3649383 Dead/Cancelled |
MARTIN PROFESSIONAL APS 2008-01-07 |