Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K901337 |
FOIA Releasable 510(k) |
K901337
|
Device Name |
HILAL EMBOLIZATION MICROCOIL(TM) |
Applicant |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
APRIL LAVENDER |
Correspondent |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
APRIL LAVENDER |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 03/22/1990 |
Decision Date | 11/13/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|