The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Endo-med Tube For Endotracheal Med.
| Device ID | K810059 |
| 510k Number | K810059 |
| Device Name: | ENDO-MED TUBE FOR ENDOTRACHEAL MED |
| Classification | Applicator (laryngo-tracheal), Topical Anesthesia |
| Applicant | ACKRAD LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCT |
| CFR Regulation Number | 868.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-13 |
| Decision Date | 1981-02-26 |