Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K122425 |
Device Name |
VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT |
Applicant |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Applicant Contact |
YAYOI FUJIMAKI |
Correspondent |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
YAYOI FUJIMAKI |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/09/2012 |
Decision Date | 11/05/2012 |
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
|