Device Classification Name |
Permanent Pacemaker Electrode
|
510(k) Number |
K760714 |
Device Name |
ENDO-LOK L-40 ENDOCARDIAL PACING ELECT. |
Applicant |
CORATOMIC, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CORATOMIC, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 09/25/1976 |
Decision Date | 12/14/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|