Device Classification Name |
needle, fistula
|
510(k) Number |
K112178 |
Device Name |
JMS APHERESIS NEEDLE SET WINGEATER(R) V2 |
Applicant |
JMS NORTH AMERICA CORPORATION |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Applicant Contact |
E.J. Smith |
Correspondent |
JMS NORTH AMERICA CORPORATION |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Correspondent Contact |
E.J. Smith |
Regulation Number | 876.5540
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/28/2011 |
Decision Date | 10/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|