Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K181814 |
Device Name |
AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water |
Applicant |
Amsino International, Inc. |
708 Corporate Center Drive |
Pomona,
CA
91768
|
|
Applicant Contact |
Cathy Hong |
Correspondent |
Amsino International, Inc. |
708 Corporate Center Drive |
Pomona,
CA
91768
|
|
Correspondent Contact |
Cathy Hong |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 07/09/2018 |
Decision Date | 09/04/2018 |
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
|
|
|