The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Sims Blue Line Endobronchial Tube.
| Device ID | K953483 |
| 510k Number | K953483 |
| Device Name: | SIMS BLUE LINE ENDOBRONCHIAL TUBE |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (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 | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-25 |
| Decision Date | 1995-10-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55019315058644 | K953483 | 000 |
| 35019315058534 | K953483 | 000 |
| 35019315058558 | K953483 | 000 |
| 55019315058569 | K953483 | 000 |
| 35019315058572 | K953483 | 000 |
| 55019315058583 | K953483 | 000 |
| 55019315058590 | K953483 | 000 |
| 35019315058602 | K953483 | 000 |
| 35019315058619 | K953483 | 000 |
| 35019315058626 | K953483 | 000 |
| 35019315058633 | K953483 | 000 |
| 35019315058527 | K953483 | 000 |