Device Classification Name |
Implantable Pacemaker Pulse-Generator
|
510(k) Number |
K810884 |
Device Name |
#325 PROGRAMMABLE CARD. PULSE GENERATOR |
Applicant |
COOK PACEMAKER CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
COOK PACEMAKER CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.3610
|
Classification Product Code |
|
Date Received | 04/01/1981 |
Decision Date | 06/16/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|