Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K082464 |
Device Name |
PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 |
Applicant |
MEDTRONIC INC. |
710 MEDTRONIC PARKWAY NE |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
JEANMARIE SALES |
Correspondent |
MEDTRONIC INC. |
710 MEDTRONIC PARKWAY NE |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
JEANMARIE SALES |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/27/2008 |
Decision Date | 10/27/2008 |
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
|
|
|