Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K111732 |
Device Name |
AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER |
Applicant |
SALIENT SURGICAL TECHNOLOGIES, INC. |
180 INTERNATIONAL DRIVE |
PORTSMOUTH,
NH
03801
|
|
Applicant Contact |
MARTIN J LEIGHTON |
Correspondent |
SALIENT SURGICAL TECHNOLOGIES, INC. |
180 INTERNATIONAL DRIVE |
PORTSMOUTH,
NH
03801
|
|
Correspondent Contact |
MARTIN J LEIGHTON |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/20/2011 |
Decision Date | 12/05/2011 |
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
|