The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Per-fit Percutaneous Dilational Tracheostomy Kit.
| Device ID | K031057 |
| 510k Number | K031057 |
| Device Name: | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott PORTEX, INC. 10 BOWMAN DR. 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 | 2003-04-03 |
| Decision Date | 2003-07-18 |
| Summary: | summary |