The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Xomed Treace Jet Ventilation Tube.
| Device ID | K922880 |
| 510k Number | K922880 |
| Device Name: | XOMED TREACE JET VENTILATION TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Contact | Terry C Mcmahon |
| Correspondent | Terry C Mcmahon XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-15 |
| Decision Date | 1993-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490156431 | K922880 | 000 |