The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek Endotracheal Tube, Laser Resis.
| Device ID | K823757 |
| 510k Number | K823757 |
| Device Name: | SURGITEK ENDOTRACHEAL TUBE, LASER RESIS |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MEDICAL ENGINEERING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-14 |
| Decision Date | 1983-04-28 |