Device Classification Name |
introducer, catheter
|
510(k) Number |
K831751 |
Device Name |
LEAD INTRODUCER SETS-EB-S8 & EB-S12 |
Applicant |
Oscor Inc. |
3816 DeSoto Blvd. |
Palm Harbor,
FL
34683
|
|
Correspondent |
Oscor Inc. |
3816 DeSoto Blvd. |
Palm Harbor,
FL
34683
|
|
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 06/01/1983 |
Decision Date | 10/20/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|