The following data is part of a premarket notification filed by Mallinckrodt, Inc. with the FDA for Shiley Tracheosoft Xlt Extended Length Tracheostomy Tube And Disposable Inner Cannula.
| Device ID | K003315 |
| 510k Number | K003315 |
| Device Name: | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | MALLINCKRODT, INC. 3 MISSOURI RESEARCH PARK DR. St. Charles, MO 63304 |
| Contact | James C Keeven |
| Correspondent | James C Keeven MALLINCKRODT, INC. 3 MISSOURI RESEARCH PARK DR. St. Charles, MO 63304 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-23 |
| Decision Date | 2000-11-08 |