Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K121488 |
Device Name |
JMS SAFE WING CATH (SWC) |
Applicant |
JMS NORTH AMERICA CORPORATION |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Applicant Contact |
YOLANDA SMITH |
Correspondent |
JMS NORTH AMERICA CORPORATION |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Correspondent Contact |
YOLANDA SMITH |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 05/18/2012 |
Decision Date | 03/05/2013 |
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
|
|
|