The following data is part of a premarket notification filed by Centese, Inc. with the FDA for Thoraguard System.
| Device ID | K181667 |
| 510k Number | K181667 |
| Device Name: | Thoraguard System |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | Centese, Inc. 3929 Harney St Suite 3008 Omaha, NE 68131 |
| Contact | Evan Luxon |
| Correspondent | Evan Luxon Centese, Inc. 3929 Harney St Suite 3008 Omaha, NE 68131 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2018-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860000436424 | K181667 | 000 |
| 10860000436417 | K181667 | 000 |