The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Disposable Cannula Trach. Tube.
| Device ID | K811447 |
| 510k Number | K811447 |
| Device Name: | SHILEY DISPOSABLE CANNULA TRACH. TUBE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | SHILEY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-22 |
| Decision Date | 1981-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40884522005327 | K811447 | 000 |
| 50884522005287 | K811447 | 000 |
| 50884522005249 | K811447 | 000 |
| 50884522005201 | K811447 | 000 |