Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K900723 |
Device Name |
ITC BUNJI COIL |
Applicant |
INTERVENTIONAL THERAPEUTICS CORP. |
385 OYSTER POINT BLVD. |
SUITE 6 |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Applicant Contact |
JULIE D BELL |
Correspondent |
INTERVENTIONAL THERAPEUTICS CORP. |
385 OYSTER POINT BLVD. |
SUITE 6 |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Correspondent Contact |
JULIE D BELL |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 02/15/1990 |
Decision Date | 02/19/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|