The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for T-wall Uncuffed Tracheal Tube.
| Device ID | K970196 |
| 510k Number | K970196 |
| Device Name: | T-WALL UNCUFFED TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Anthony P Martino |
| Correspondent | Anthony P Martino VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-08-21 |