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 |