Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K063742 |
Device Name |
RESONANCE METALLIC URETERAL STENT |
Applicant |
COOK IRELAND LTD |
O'HALLORAN ROAD |
NATIONAL TECHNOLOGY PARK |
LIMERICK,
IE
|
|
Applicant Contact |
SINEAD BURKE |
Correspondent |
COOK IRELAND LTD |
O'HALLORAN ROAD |
NATIONAL TECHNOLOGY PARK |
LIMERICK,
IE
|
|
Correspondent Contact |
SINEAD BURKE |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 12/18/2006 |
Decision Date | 05/08/2007 |
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
|
|
|