Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K113380 |
Device Name |
PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR |
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 | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/16/2011 |
Decision Date | 11/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|