The following data is part of a premarket notification filed by Well Lead Medical Instruments with the FDA for Well Lead Tracheostomy Tube.
| Device ID | K042684 |
| 510k Number | K042684 |
| Device Name: | WELL LEAD TRACHEOSTOMY TUBE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | WELL LEAD MEDICAL INSTRUMENTS 962 ALLERGO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward WELL LEAD MEDICAL INSTRUMENTS 962 ALLERGO LANE Apollo Beach, FL 33572 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-29 |
| Decision Date | 2005-02-17 |
| Summary: | summary |