The following data is part of a premarket notification filed by Well Lead Medical Instruments with the FDA for Well Lead Reinforced Endotracheal Tube.
| Device ID | K073383 |
| 510k Number | K073383 |
| Device Name: | WELL LEAD REINFORCED ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | WELL LEAD MEDICAL INSTRUMENTS 962 ALLERGO LANE Apollo Beach, FL 33572 |
| Contact | Arthur J Ward |
| Correspondent | Arthur J Ward WELL LEAD MEDICAL INSTRUMENTS 962 ALLERGO LANE Apollo Beach, FL 33572 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-03 |
| Decision Date | 2008-07-10 |
| Summary: | summary |