Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K182248 |
Device Name |
Aspire Venting Tube |
Applicant |
Aspire Bariatrics, Inc |
3200 Horizon Dirve |
Suite 100 |
King of Prussia,
PA
19406
|
|
Applicant Contact |
Monica Ferrante |
Correspondent |
Aspire Bariatrics, Inc |
3200 Horizon Dirve |
Suite 100 |
King of Prussia,
PA
19406
|
|
Correspondent Contact |
Monica Ferrante |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 08/20/2018 |
Decision Date | 11/13/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|