Device Classification Name |
Electrode, Electrosurgical, Active, Urological
|
510(k) Number |
K053322 |
Device Name |
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS |
Applicant |
ROEI MEDICAL TECHNOLOGIES, LTD. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHN |
Correspondent |
ROEI MEDICAL TECHNOLOGIES, LTD. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHN |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 11/30/2005 |
Decision Date | 01/06/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|