Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K093919 |
Device Name |
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V |
Applicant |
MICROVENTION, INC. |
1311 VALENCIA AVE |
TUSTIN,
CA
92780
|
|
Applicant Contact |
LARAINE PANGELINA |
Correspondent |
MICROVENTION, INC. |
1311 VALENCIA AVE |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
LARAINE PANGELINA |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 12/22/2009 |
Decision Date | 01/21/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|