Device Classification Name |
syringe, piston
|
510(k) Number |
K182279 |
Device Name |
Merit Syringe |
Applicant |
Merit Medical Systems, Inc. |
1600W Merit Parkway |
South Jordan,
UT
84095
|
|
Applicant Contact |
John Skousen |
Correspondent |
Merit Medical Systems, Inc. |
1600W Merit Parkway |
South Jordan,
UT
84095
|
|
Correspondent Contact |
John Skousen |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 08/22/2018 |
Decision Date | 11/06/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|