The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Uniperc Percutaneous Dilation Tracheostomy Kit.
| Device ID | K083031 |
| 510k Number | K083031 |
| Device Name: | PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | SMITHS MEDICAL ASD, INC. BOUNDARY ROAD Hythe, Kent, GB Ct216jn |
| Contact | John Tullett |
| Correspondent | John Tullett SMITHS MEDICAL ASD, INC. BOUNDARY ROAD Hythe, Kent, GB Ct216jn |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-10 |
| Decision Date | 2009-08-18 |
| Summary: | summary |