Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K002181 |
Device Name |
GDC ULTRASOFT COIL |
Applicant |
BOSTON SCIENTIFIC, TARGET |
47900 BAYSIDE PKWY. |
FREMONT,
CA
94538
|
|
Applicant Contact |
JAMES LEATHLEY |
Correspondent |
BOSTON SCIENTIFIC, TARGET |
47900 BAYSIDE PKWY. |
FREMONT,
CA
94538
|
|
Correspondent Contact |
JAMES LEATHLEY |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 07/19/2000 |
Decision Date | 08/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|