The following data is part of a premarket notification filed by Erie Medical with the FDA for Tracheal Tube 16 Gauge-1.65mm-.
| Device ID | K832466 |
| 510k Number | K832466 |
| Device Name: | TRACHEAL TUBE 16 GAUGE-1.65MM- |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | ERIE MEDICAL 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-26 |
| Decision Date | 1984-09-19 |