Device Classification Name |
System, Suction, Lipoplasty
|
510(k) Number |
K121703 |
Device Name |
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE |
Applicant |
MEDI-KHAN USA, INC |
399 MASSACHUSETTS AVE. #2 |
BOSTON,
MA
02115
|
|
Applicant Contact |
KACHI ENYINNA |
Correspondent |
MEDI-KHAN USA, INC |
399 MASSACHUSETTS AVE. #2 |
BOSTON,
MA
02115
|
|
Correspondent Contact |
KACHI ENYINNA |
Regulation Number | 878.5040
|
Classification Product Code |
|
Date Received | 06/08/2012 |
Decision Date | 12/07/2012 |
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
|