Device Classification Name |
biopsy needle
|
510(k) Number |
K180363 |
Device Name |
Clear-Tip EUS-FNA |
Applicant |
Finemedix Co. Ltd. |
60, Maeyeo-ro, Dong-gu |
Daegu,
KR
41065
|
|
Applicant Contact |
Heon Sik Lee |
Correspondent |
Withus Group Inc |
106 Superior |
Irvine,
CA
92620
|
|
Correspondent Contact |
April Lee |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 02/09/2018 |
Decision Date | 11/01/2018 |
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
|
|
|