Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K111939 |
Device Name |
M/29TM - PRESSURE INJECTABLE |
Applicant |
FLEXICATH LTD. |
120 YIGAL ALON ST. |
CALIFORNIA BLDG, SUITE 107 |
TEL AVIV,
IL
67443
|
|
Applicant Contact |
TALI HAZAN |
Correspondent |
FLEXICATH LTD. |
120 YIGAL ALON ST. |
CALIFORNIA BLDG, SUITE 107 |
TEL AVIV,
IL
67443
|
|
Correspondent Contact |
TALI HAZAN |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 07/08/2011 |
Decision Date | 07/11/2012 |
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
|
|
|