Device Classification Name |
device, surgical, cryogenic
|
510(k) Number |
K142866 |
Device Name |
Myoscience iovera system |
Applicant |
Myoscience, Inc |
1600 Seaport Blvd, North Lobby, Suite 450 |
Redwood City,
CA
94063 2
|
|
Applicant Contact |
Tracey Henry |
Correspondent |
Myoscience, Inc |
1600 Seaport Blvd, North Lobby, Suite 450 |
Redwood City,
CA
94063 2
|
|
Correspondent Contact |
Tracey Henry |
Regulation Number | 882.4250
|
Classification Product Code |
|
Date Received | 10/01/2014 |
Decision Date | 01/21/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|