Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K111285 |
Device Name |
AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING |
Applicant |
SALIENT SURGICAL TECHNOLOGIES, INC. |
180 INTERNATIONAL DRIVE |
PORTSMOUTH,
NH
03801
|
|
Applicant Contact |
RITA M CALNAN |
Correspondent |
SALIENT SURGICAL TECHNOLOGIES, INC. |
180 INTERNATIONAL DRIVE |
PORTSMOUTH,
NH
03801
|
|
Correspondent Contact |
RITA M CALNAN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/06/2011 |
Decision Date | 09/09/2011 |
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
|