Device Classification Name |
pacemaker lead adaptor
|
510(k) Number |
K010787 |
Device Name |
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS |
Applicant |
Oscor Inc. |
3816 DeSoto Blvd. |
Palm Harbor,
FL
34683
|
|
Applicant Contact |
MILA DOSKOCIL |
Correspondent |
Oscor Inc. |
3816 DeSoto Blvd. |
Palm Harbor,
FL
34683
|
|
Correspondent Contact |
MILA DOSKOCIL |
Regulation Number | 870.3620
|
Classification Product Code |
|
Date Received | 03/15/2001 |
Decision Date | 05/22/2001 |
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
|
|
|