Device Classification Name |
Implantable Pacemaker Pulse-Generator
|
510(k) Number |
K863582 |
Device Name |
MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) |
Applicant |
COOK PACEMAKER CORP. |
P.O. BOX 529 |
LEECHBURG,
PA
15656
|
|
Applicant Contact |
RICHARD E SHIREY |
Correspondent |
COOK PACEMAKER CORP. |
P.O. BOX 529 |
LEECHBURG,
PA
15656
|
|
Correspondent Contact |
RICHARD E SHIREY |
Regulation Number | 870.3610 |
Classification Product Code |
|
Date Received | 09/15/1986 |
Decision Date | 10/08/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|