Device Classification Name |
Biopsy Needle
|
510(k) Number |
K151895 |
Device Name |
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle |
Applicant |
BOSTON SCIENTIFIC CORPORATION |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
YINGYING GAO |
Correspondent |
BOSTON SCIENTIFIC CORPORATION |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
YINGYING GAO |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 07/10/2015 |
Decision Date | 10/22/2015 |
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
|
|
|