Device Classification Name |
System, Ablation, Microwave And Accessories
|
510(k) Number |
K122762 |
FOIA Releasable 510(k) |
K122762
|
Device Name |
ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR |
Applicant |
MICROSULIS MEDICAL LIMITED |
UNIT 1 AND 2 FALSON COURT |
PARKLANDS BUSINESS PARK |
DENMEAD,
GB
PO7 7XP
|
|
Applicant Contact |
STUART MCINTYRE |
Correspondent |
MICROSULIS MEDICAL LIMITED |
UNIT 1 AND 2 FALSON COURT |
PARKLANDS BUSINESS PARK |
DENMEAD,
GB
PO7 7XP
|
|
Correspondent Contact |
STUART MCINTYRE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/10/2012 |
Decision Date | 11/30/2012 |
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
|