Device Classification Name |
permanent pacemaker electrode
|
510(k) Number |
K813134 |
Device Name |
ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP |
Applicant |
TELECTRONICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
TELECTRONICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 11/05/1981 |
Decision Date | 12/10/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|