Device Classification Name |
Gastroscope And Accessories, Flexible/Rigid
|
510(k) Number |
K232314 |
Device Name |
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) |
Applicant |
Fujifilm Healthcare Americas Corporation |
81 Hartwell Avenue |
Suite 300 |
Lexington,
MA
02421
|
|
Applicant Contact |
Chaitrali Kulkarni |
Correspondent |
Fujifilm Healthcare Americas Corporation |
81 Hartwell Avenue |
Suite 300 |
Lexington,
MA
02421
|
|
Correspondent Contact |
Chaitrali Kulkarni |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/02/2023 |
Decision Date | 09/01/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|