Device Classification Name |
System, Ablation, Microwave And Accessories
|
510(k) Number |
K011676 |
Device Name |
VIVAWAVE MICROWAVE SYSTEM |
Applicant |
VIVANT MEDICAL, INC. |
1916-A OLD MIDDLEFIELD WAY |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
STEVEN KIM |
Correspondent |
VIVANT MEDICAL, INC. |
1916-A OLD MIDDLEFIELD WAY |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
STEVEN KIM |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/30/2001 |
Decision Date | 06/18/2002 |
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
|