Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K131020 |
Device Name |
TEMPERATURE SENSOR CATHETER |
Applicant |
DEGANIA SILICONE, LTD. |
KIBBUTZ DEGANIA BET |
ISRAEL,
IL
15130
|
|
Applicant Contact |
ZOYA LEE |
Correspondent |
DEGANIA SILICONE, LTD. |
KIBBUTZ DEGANIA BET |
ISRAEL,
IL
15130
|
|
Correspondent Contact |
ZOYA LEE |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 04/12/2013 |
Decision Date | 05/09/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|