Device Classification Name |
biopsy needle
|
510(k) Number |
K181994 |
Device Name |
Single Use Aspiration Needle NA-U201H |
Applicant |
Olympus Medical Systems Corp. |
2951 Ishikawa-cho |
Hachioji-Shi,
JP
192-8507
|
|
Applicant Contact |
Toshiyuki Nakajima |
Correspondent |
Olympus Surgical Technologies America |
136 Turnpike Road |
Southborough,
MA
01772
|
|
Correspondent Contact |
Mary Anne Patella |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 07/26/2018 |
Decision Date | 10/31/2018 |
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
|
|
|