The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Portex Adjustable Flange Tracheostomy Tube.
| Device ID | K962175 |
| 510k Number | K962175 |
| Device Name: | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE |
| Classification | Tube Tracheostomy And Tube Cuff |
| 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 | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-05 |
| Decision Date | 1997-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315016169 | K962175 | 000 |
| 35019315015865 | K962175 | 000 |
| 35019315015872 | K962175 | 000 |
| 35019315016107 | K962175 | 000 |
| 35019315016114 | K962175 | 000 |
| 35019315016121 | K962175 | 000 |
| 35019315016138 | K962175 | 000 |
| 35019315016145 | K962175 | 000 |
| 55019315016156 | K962175 | 000 |
| 35019315015858 | K962175 | 000 |