Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K092879 |
Device Name |
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER |
Applicant |
VALLEYLAB |
5920 LONGBOW DR. |
BOULDER,
CO
80301
|
|
Applicant Contact |
PHILIP E AKE |
Correspondent |
VALLEYLAB |
5920 LONGBOW DR. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
PHILIP E AKE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/18/2009 |
Decision Date | 10/16/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|