Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K050578 |
Device Name |
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE |
Applicant |
COOK IRELAND LTD |
O'HOLLORAN ROAD |
NATIONAL TECHNOLOGICAL PARK |
LIMERICK,
IE
|
|
Applicant Contact |
EMMETT DEVEREUX |
Correspondent |
COOK IRELAND LTD |
O'HOLLORAN ROAD |
NATIONAL TECHNOLOGICAL PARK |
LIMERICK,
IE
|
|
Correspondent Contact |
EMMETT DEVEREUX |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 03/07/2005 |
Decision Date | 04/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|