Device Classification Name |
System, Suction, Lipoplasty For Removal
|
510(k) Number |
K110255 |
Device Name |
SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM |
Applicant |
SOUND SURGICAL TECHNOLOGIES LLC. |
357 S. MCCASLIN BLVD. #100 |
LOUISVILLE,
CO
80027
|
|
Applicant Contact |
STEPHEN C SMITH |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 878.5040
|
Classification Product Code |
|
Date Received | 01/28/2011 |
Decision Date | 04/04/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|