Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K913556 |
Device Name |
IVALON EMBOLIZATION PARTICLES |
Applicant |
IVALON |
5374 LINDA VISTA RD., SUITE C |
SAN DIEGO,
CA
92110
|
|
Applicant Contact |
ELIZABETH MELARAGNO |
Correspondent |
IVALON |
5374 LINDA VISTA RD., SUITE C |
SAN DIEGO,
CA
92110
|
|
Correspondent Contact |
ELIZABETH MELARAGNO |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 08/09/1991 |
Decision Date | 04/13/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|