Device Classification Name |
Saline, Vascular Access Flush
|
510(k) Number |
K213522 |
Device Name |
AMSafe Pre-Filled Normal Saline Flush Syringe |
Applicant |
Amsino International, Inc. |
708 Corporate Center Drive |
Pomona,
CA
91768
|
|
Applicant Contact |
Jane Gao |
Correspondent |
Amsino International, Inc. |
708 Corporate Center Drive |
Pomona,
CA
91768
|
|
Correspondent Contact |
Jane Gao |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 11/03/2021 |
Decision Date | 03/22/2022 |
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
|
|
|