The following data is part of a premarket notification filed by Unomedical Sdn Bhd with the FDA for Pediatric Wire Reinforced Silicone Endotracheal Tube.
| Device ID | K954750 |
| 510k Number | K954750 |
| Device Name: | PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | UNOMEDICAL SDN BHD P.O. BOX NO. 18 SUNGEI PATANI KEDAH West Malaysia, MY |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb UNOMEDICAL SDN BHD P.O. BOX NO. 18 SUNGEI PATANI KEDAH West Malaysia, MY |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-16 |
| Decision Date | 1995-12-08 |