The following data is part of a premarket notification filed by Unomedical Sdn Bhd with the FDA for Euromedical Reinforced Endotracheal Tube.
| Device ID | K962389 |
| 510k Number | K962389 |
| Device Name: | EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | UNOMEDICAL SDN BHD 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb UNOMEDICAL SDN BHD 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-20 |
| Decision Date | 1996-11-21 |