The following data is part of a premarket notification filed by Vitaid, Ltd. with the FDA for Univent Tube 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm.
| Device ID | K894337 |
| 510k Number | K894337 |
| Device Name: | UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | VITAID, LTD. P.O. BOX 123 POSTAL STATION S., TORONTO Ontario, Canada, CA M5m 4l6 |
| Contact | William G Stewart |
| Correspondent | William G Stewart VITAID, LTD. P.O. BOX 123 POSTAL STATION S., TORONTO Ontario, Canada, CA M5m 4l6 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04544050080965 | K894337 | 000 |
| 14544050123928 | K894337 | 000 |
| 14544050123829 | K894337 | 000 |
| 14544050123805 | K894337 | 000 |
| 14544050123904 | K894337 | 000 |
| 14544050123898 | K894337 | 000 |
| 14544050123881 | K894337 | 000 |
| 14544050123874 | K894337 | 000 |
| 14544050123867 | K894337 | 000 |
| 14544050123850 | K894337 | 000 |
| 14544050123843 | K894337 | 000 |
| 14544050123836 | K894337 | 000 |
| 04544050123914 | K894337 | 000 |
| 04544050055154 | K894337 | 000 |
| 04544050063715 | K894337 | 000 |
| 04544050056076 | K894337 | 000 |
| 04544050056069 | K894337 | 000 |
| 04544050056052 | K894337 | 000 |
| 04544050056045 | K894337 | 000 |
| 04544050056038 | K894337 | 000 |
| 04544050056021 | K894337 | 000 |
| 04544050056014 | K894337 | 000 |
| 04544050056007 | K894337 | 000 |
| 04544050055987 | K894337 | 000 |
| 04544050055161 | K894337 | 000 |
| 14544050123812 | K894337 | 000 |