Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K182463 |
Device Name |
Silicone Foley Catheter |
Applicant |
Biosensors International Pte Ltd |
36 Jalan Tukang |
Singapore,
SG
619266
|
|
Applicant Contact |
Lor Yen Yin |
Correspondent |
Biosensors International Pte Ltd |
36 Jalan Tukang |
Singapore,
SG
619266
|
|
Correspondent Contact |
Jane Chen |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 09/10/2018 |
Decision Date | 11/06/2019 |
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
|
|
|