The following data is part of a premarket notification filed by Concord/portex with the FDA for Tracheostomy Tube And Cuff.
| Device ID | K912124 |
| 510k Number | K912124 |
| Device Name: | TRACHEOSTOMY TUBE AND CUFF |
| 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 | 1991-05-13 |
| Decision Date | 1991-08-16 |