The following data is part of a premarket notification filed by Covidien with the FDA for Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy T.
| Device ID | K122531 |
| 510k Number | K122531 |
| Device Name: | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80021 |
| Contact | Ted Kuhn |
| Correspondent | Ted Kuhn COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80021 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-20 |
| Decision Date | 2012-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521096353 | K122531 | 000 |
| 10884521779761 | K122531 | 000 |
| 10884521779754 | K122531 | 000 |
| 10884521779747 | K122531 | 000 |
| 10884521779624 | K122531 | 000 |
| 10884521779617 | K122531 | 000 |
| 10884521779600 | K122531 | 000 |
| 10884521779594 | K122531 | 000 |
| 10884521779587 | K122531 | 000 |
| 20884521103440 | K122531 | 000 |
| 20884521103433 | K122531 | 000 |
| 20884521097312 | K122531 | 000 |
| 20884521097305 | K122531 | 000 |
| 20884521097299 | K122531 | 000 |
| 20884521097282 | K122531 | 000 |
| 10884521779778 | K122531 | 000 |
| 10884521779785 | K122531 | 000 |
| 10884521101623 | K122531 | 000 |
| 10884521101616 | K122531 | 000 |
| 10884521101609 | K122531 | 000 |
| 10884521101593 | K122531 | 000 |
| 10884521101586 | K122531 | 000 |
| 10884521101579 | K122531 | 000 |
| 10884521101562 | K122531 | 000 |
| 10884521101555 | K122531 | 000 |
| 10884521779907 | K122531 | 000 |
| 10884521779891 | K122531 | 000 |
| 10884521779884 | K122531 | 000 |
| 10884521779877 | K122531 | 000 |
| 10884521779808 | K122531 | 000 |
| 10884521779792 | K122531 | 000 |
| 20884521101637 | K122531 | 000 |