Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K121290 |
Device Name |
AQUAMANTRYS3 BSC 9.1S |
Applicant |
MEDTRONIC INC. |
180 INTERNATIONAL DRIVE |
PORTSMOUTH,
NH
03801
|
|
Applicant Contact |
TARA N TURNEY |
Correspondent |
MEDTRONIC INC. |
180 INTERNATIONAL DRIVE |
PORTSMOUTH,
NH
03801
|
|
Correspondent Contact |
TARA N TURNEY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/30/2012 |
Decision Date | 06/25/2012 |
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
|