Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K053429 |
Device Name |
ADVANCED UROLOGICAL CATHETER |
Applicant |
ENTRACARE, LLC |
11315 STRANG LINE RD. |
LENEXA,
KS
66215
|
|
Applicant Contact |
AL BOEDEKER |
Correspondent |
ENTRACARE, LLC |
11315 STRANG LINE RD. |
LENEXA,
KS
66215
|
|
Correspondent Contact |
AL BOEDEKER |
Regulation Number | 876.5130
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/09/2005 |
Decision Date | 02/08/2006 |
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
|
|
|