Device Classification Name |
pump, portable, aspiration (manual or powered)
|
510(k) Number |
K181667 |
Device Name |
Thoraguard System |
Applicant |
Centese, Inc. |
3929 Harney St Suite 3008 |
Omaha,
NE
68131
|
|
Applicant Contact |
Evan Luxon |
Correspondent |
Centese, Inc. |
3929 Harney St Suite 3008 |
Omaha,
NE
68131
|
|
Correspondent Contact |
Evan Luxon |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 06/25/2018 |
Decision Date | 11/29/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|