The following data is part of a premarket notification filed by Exidyne, Inc. with the FDA for Endo-secure.
| Device ID | K840844 |
| 510k Number | K840844 |
| Device Name: | ENDO-SECURE |
| Classification | Support, Breathing Tube |
| Applicant | EXIDYNE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JAY |
| CFR Regulation Number | 868.5280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-03-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDO-SECURE 73499831 1336492 Dead/Cancelled |
Exidyne, Inc. 1984-09-17 |