Device Classification Name |
Needle, Fistula
|
510(k) Number |
K131950 |
Device Name |
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET |
Applicant |
SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC. |
7 MEADOW WOOD ROAD |
KINGSTON,
NH
03848
|
|
Applicant Contact |
RICHELLE HELMAN |
Correspondent |
SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC. |
7 MEADOW WOOD ROAD |
KINGSTON,
NH
03848
|
|
Correspondent Contact |
RICHELLE HELMAN |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 06/27/2013 |
Decision Date | 01/16/2015 |
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
|
|
|