The following data is part of a premarket notification filed by Mentor Medical Limited with the FDA for Portex Percutaneous Dilatational Tracheostomy Kits.
| Device ID | K022212 |
| 510k Number | K022212 |
| Device Name: | PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | MENTOR MEDICAL LIMITED MILITARY ROAD Hythe, Kent, GB Ct21 6db |
| Contact | Steve Ogilvie |
| Correspondent | Steve Ogilvie MENTOR MEDICAL LIMITED MILITARY ROAD Hythe, Kent, GB Ct21 6db |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-08 |
| Decision Date | 2003-03-21 |
| Summary: | summary |