The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Tracheal Tube, Sizes 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5.
| Device ID | K083119 |
| 510k Number | K083119 |
| Device Name: | PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | SMITHS MEDICAL ASD, INC. BOUNDARY ROAD Hythe, Kent, GB Ct216jn |
| Contact | John Tullett |
| Correspondent | John Tullett SMITHS MEDICAL ASD, INC. BOUNDARY ROAD Hythe, Kent, GB Ct216jn |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-22 |
| Decision Date | 2009-06-26 |
| Summary: | summary |