Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K141983 |
Device Name |
NEUROBLATE SYSTEM |
Applicant |
MONTERIS MEDICAL CORP |
1193 SHERMAN STREET |
ALAMEDA,
CA
94501
|
|
Applicant Contact |
CRAIG COOMBS |
Correspondent |
MONTERIS MEDICAL CORP |
1193 SHERMAN STREET |
ALAMEDA,
CA
94501
|
|
Correspondent Contact |
CRAIG COOMBS |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/21/2014 |
Decision Date | 08/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|