Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K210437 |
Device Name |
Standard Bougie, 38 Fr. |
Applicant |
Standard Bariatrics |
4362 Glendale Milford Rd. |
Cincinnati,
OH
45242
|
|
Applicant Contact |
Michelle Schnell |
Correspondent |
Standard Bariatrics |
4362 Glendale Milford Rd. |
Cincinnati,
OH
45242
|
|
Correspondent Contact |
Michelle Schnell |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 02/12/2021 |
Decision Date | 06/29/2021 |
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
|
|
|