The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Blue Line(r) Pdt(tm) Portex Directional Tube.
| Device ID | K931735 |
| 510k Number | K931735 |
| Device Name: | BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE |
| 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 | 1993-04-07 |
| Decision Date | 1993-05-18 |