The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Dic Tracheostomy Tube And Portex Blue Line.
| Device ID | K934465 |
| 510k Number | K934465 |
| Device Name: | DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-13 |
| Decision Date | 1994-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688036933 | K934465 | 000 |
| 10351688000231 | K934465 | 000 |
| 10351688000644 | K934465 | 000 |
| 10351688001481 | K934465 | 000 |
| 10351688006677 | K934465 | 000 |
| 10351688009265 | K934465 | 000 |
| 10351688010339 | K934465 | 000 |
| 10351688017772 | K934465 | 000 |
| 10351688021007 | K934465 | 000 |
| 10351688022066 | K934465 | 000 |
| 10351688023544 | K934465 | 000 |
| 10351688024923 | K934465 | 000 |
| 10351688027900 | K934465 | 000 |
| 10351688033161 | K934465 | 000 |
| 10351688036117 | K934465 | 000 |
| 10351688018243 | K934465 | 000 |