Device Classification Name |
Agents, Embolic, For Treatment Of Uterine Fibroids
|
510(k) Number |
K100663 |
Device Name |
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 |
Applicant |
Boston Scientific Corporation |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
DEBBIE MCINTIRE |
Correspondent |
Boston Scientific Corporation |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
DEBBIE MCINTIRE |
Regulation Number | 870.3300
|
Classification Product Code |
|
Date Received | 03/08/2010 |
Decision Date | 04/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|