Device Classification Name |
Needle, Fistula
|
510(k) Number |
K134019 |
Device Name |
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO |
Applicant |
NXSTAGE MEDICAL, INC. |
350 MERRIMACK STREET |
LAWRENCE,
MA
01843
|
|
Applicant Contact |
LAURA F PLATH |
Correspondent |
NXSTAGE MEDICAL, INC. |
350 MERRIMACK STREET |
LAWRENCE,
MA
01843
|
|
Correspondent Contact |
LAURA F PLATH |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 12/30/2013 |
Decision Date | 09/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|