Device Classification Name |
system, suction, lipoplasty for removal
|
510(k) Number |
K022051 |
Device Name |
SOUNDVASER SYSTEM |
Applicant |
SOUND SURGICAL TECHNOLOGIES LLC. |
1300 PLAZA CT. NORTH, #103 |
LAFAYETTE,
CO
80026
|
|
Applicant Contact |
WILLIAM W CIMINO |
Correspondent |
SOUND SURGICAL TECHNOLOGIES LLC. |
1300 PLAZA CT. NORTH, #103 |
LAFAYETTE,
CO
80026
|
|
Correspondent Contact |
WILLIAM W CIMINO |
Regulation Number | 878.5040
|
Classification Product Code |
|
Date Received | 06/24/2002 |
Decision Date | 09/11/2002 |
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
|
|
|