Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K150029 |
Device Name |
Habib EUS RFA |
Applicant |
EMCISION, LTD. |
DUCANE ROAD |
LONDON,
GB
W12 0HS
|
|
Applicant Contact |
FRANCOIS POULIN |
Correspondent |
MMA CERTIFICATION INC. |
2025 MICHELIN |
LAVAL,
CA
H7L5B7
|
|
Correspondent Contact |
LOUIS-PAUL MARIN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/08/2015 |
Decision Date | 06/24/2015 |
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
|