Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K120909 |
Device Name |
EC 2.7 ENDOSCOPIC CUTTER |
Applicant |
MEDTRONIC ADVANCED ENERGY, LLC |
180 INTERNATIONAL DRIVE |
PORTSMOUTH,
NH
03801
|
|
Applicant Contact |
MARTIN J LEIGHTON |
Correspondent |
MEDTRONIC ADVANCED ENERGY, LLC |
180 INTERNATIONAL DRIVE |
PORTSMOUTH,
NH
03801
|
|
Correspondent Contact |
MARTIN J LEIGHTON |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/26/2012 |
Decision Date | 11/02/2012 |
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
|
|
|