Device Classification Name |
Endoscopic Injection Needle, Gastroenterology-Urology
|
510(k) Number |
K181690 |
Device Name |
Clear-Jet Injection Catheter |
Applicant |
Finemedix Co. Ltd. |
60, Maeyeo-ro, Dong-gu |
Daegu,
KR
41065
|
|
Applicant Contact |
Hee Kyung Kwon |
Correspondent |
Withus Group Inc |
106 Superior |
Irvine,
CA
92620
|
|
Correspondent Contact |
April Lee |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/26/2018 |
Decision Date | 12/21/2018 |
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
|
|
|