Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K201776 |
Device Name |
Foley Balloon Catheter for Urology |
Applicant |
Apollon co., Ltd. |
M-1804/3203, 32, Songdogwahak-ro, Yeonsu-gu |
Incheon,
KR
21984
|
|
Applicant Contact |
Donghyuk Shin |
Correspondent |
TSD Life Sciences Co., Ltd. |
211, Mallijae-ro, Jung-gu |
Seoul,
KR
04508
|
|
Correspondent Contact |
Hyeyoung Moon |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 06/29/2020 |
Decision Date | 12/30/2020 |
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
|
|
|