The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Per-fit Percutaneous Dilational Tracheostomy Kit With Specialty Tracheostomy Tube And Disposable Inner Cannula.
| Device ID | K980466 |
| 510k Number | K980466 |
| Device Name: | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott SIMS 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 | 1998-02-06 |
| Decision Date | 1998-02-24 |
| Summary: | summary |