The following data is part of a premarket notification filed by Sorenson Critical Care with the FDA for Trach-eze Closed Ventilation Suction System.
| Device ID | K961707 |
| 510k Number | K961707 |
| Device Name: | TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | SORENSON CRITICAL CARE 79 WEST 4500 SOUTH, SUITE 9 Salt Lake City, UT 84107 |
| Contact | R. Douglas Jacob |
| Correspondent | R. Douglas Jacob SORENSON CRITICAL CARE 79 WEST 4500 SOUTH, SUITE 9 Salt Lake City, UT 84107 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-02 |
| Decision Date | 1997-03-11 |