Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K101139 |
Device Name |
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE |
Applicant |
MEDTRONIC INC. |
7000 CENTRAL AVENUE NE |
MINNEAPOLIS,
MN
55432 -3576
|
|
Applicant Contact |
THOMAS REICHEL |
Correspondent |
MEDTRONIC INC. |
7000 CENTRAL AVENUE NE |
MINNEAPOLIS,
MN
55432 -3576
|
|
Correspondent Contact |
THOMAS REICHEL |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/22/2010 |
Decision Date | 05/21/2010 |
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
|
|
|