Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K193375 |
Device Name |
NeuroBlate System |
Applicant |
Monteris Medical |
14755 27th Avenue North; Suite C |
Plymouth,
MN
55447
|
|
Applicant Contact |
David H. Mueller |
Correspondent |
Monteris Medical |
14755 27th Avenue North; Suite C |
Plymouth,
MN
55447
|
|
Correspondent Contact |
David H. Mueller |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/05/2019 |
Decision Date | 01/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|