Device Classification Name |
introducer, catheter
|
510(k) Number |
K090114 |
Device Name |
MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S |
Applicant |
Oscor Inc. |
3816 DE SOTO BLVD. |
PALM HARBOR,
FL
34683
|
|
Applicant Contact |
MILA DOSKOCIL |
Correspondent |
Oscor Inc. |
3816 DE SOTO BLVD. |
PALM HARBOR,
FL
34683
|
|
Correspondent Contact |
MILA DOSKOCIL |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 01/21/2009 |
Decision Date | 06/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|