Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K121481 |
Device Name |
INFINI RADIOFREQUENCY SYSTEM |
Applicant |
LUTRONIC CORPORATION |
6 NESHAMINY INTERPLEX, |
SUITE 207 |
TREVOSE,
PA
19053
|
|
Applicant Contact |
JHUNG WON VOJIR |
Correspondent |
LUTRONIC CORPORATION |
6 NESHAMINY INTERPLEX, |
SUITE 207 |
TREVOSE,
PA
19053
|
|
Correspondent Contact |
JHUNG WON VOJIR |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/18/2012 |
Decision Date | 06/25/2013 |
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
|