The following data is part of a premarket notification filed by Concord/portex with the FDA for Low Profile Tracheostomy Tube.
| Device ID | K922749 |
| 510k Number | K922749 |
| Device Name: | LOW PROFILE TRACHEOSTOMY TUBE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Robert Wheeler |
| Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-08 |
| Decision Date | 1992-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688038715 | K922749 | 000 |