Device Classification Name |
saline, vascular access flush
|
510(k) Number |
K183473 |
Device Name |
AMSafe(R) Pre-Filled Normal Saline Flush Syringe |
Applicant |
Amsino International, Inc. |
708 Corporate Center Drive |
Pomona,
CA
91768
|
|
Applicant Contact |
Jim Barley |
Correspondent |
Amsino International, Inc. |
708 Corporate Center Drive |
Pomona,
CA
91768
|
|
Correspondent Contact |
Jim Barley |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/14/2018 |
Decision Date | 07/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|