Device Classification Name |
permanent pacemaker electrode
|
510(k) Number |
K823448 |
Device Name |
IMPLANTABLE PACING LEAD TINED #3390 & |
Applicant |
Oscor Inc. |
3816 DeSoto Blvd. |
Palm Harbor,
FL
34683
|
|
Correspondent |
Oscor Inc. |
3816 DeSoto Blvd. |
Palm Harbor,
FL
34683
|
|
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 11/16/1982 |
Decision Date | 12/03/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|