Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K103371 |
Device Name |
COUDE/ OR TIEMANN |
Applicant |
DEGANIA SILICONE, LTD. |
DEGANIA BET |
EMEK HAYARDEN,
IL
15130
|
|
Applicant Contact |
ZOYA LEE |
Correspondent |
DEGANIA SILICONE, LTD. |
DEGANIA BET |
EMEK HAYARDEN,
IL
15130
|
|
Correspondent Contact |
ZOYA LEE |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 11/17/2010 |
Decision Date | 03/11/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|