Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K122200 |
Device Name |
A3F FRATIONAL |
Applicant |
POLLOGEN LTD |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Applicant Contact |
YORAM LEVY |
Correspondent |
POLLOGEN LTD |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Correspondent Contact |
YORAM LEVY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/25/2012 |
Decision Date | 04/18/2013 |
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
|