The following data is part of a premarket notification filed by Teleflexmedical, Inc with the FDA for Sheridan Spiral-flex Endotracheal Tubes.
| Device ID | K192324 |
| 510k Number | K192324 |
| Device Name: | Sheridan Spiral-Flex Endotracheal Tubes |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | TeleflexMedical, Inc 3015 Carrington Mill Blvd , Suite 600 North Morrisville, NC 27560 |
| Contact | Lori Pfohl |
| Correspondent | Lori Pfohl TeleflexMedical, Inc 3015 Carrington Mill Blvd , Suite 600 North Morrisville, NC 27560 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-27 |
| Decision Date | 2019-12-06 |