Device Classification Name |
Syringe, Piston
|
510(k) Number |
K173601 |
Device Name |
Merit Syringe |
Applicant |
Merit Medical Systems, Inc. |
1600 W Merit Parkway |
South Jordan,
UT
84045
|
|
Applicant Contact |
Cory Marsh |
Correspondent |
Merit Medical Systems, Inc. |
1600 W Merit Parkway |
South Jordan,
UT
84045
|
|
Correspondent Contact |
Cory Marsh |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 11/21/2017 |
Decision Date | 01/31/2018 |
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
|
Recalls |
CDRH Recalls
|
|
|