The following data is part of a premarket notification filed by Concord/portex with the FDA for Modified Endobronchial Tube.
| Device ID | K902116 |
| 510k Number | K902116 |
| Device Name: | MODIFIED ENDOBRONCHIAL TUBE |
| Classification | Tube, Bronchial (w/wo Connector) |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Edwin G Grove |
| Correspondent | Edwin G Grove CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | BTS |
| CFR Regulation Number | 868.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-10 |
| Decision Date | 1990-08-03 |