Device Classification Name |
electrode, pacemaker, temporary
|
510(k) Number |
K850622 |
Device Name |
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR |
Applicant |
OSCOR MEDICAL CORP. |
KAYE, SCHOLER, FIERMAN, HAYS & |
1575 EYE STREET NW |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
ALLEN M FOX |
Correspondent |
OSCOR MEDICAL CORP. |
KAYE, SCHOLER, FIERMAN, HAYS & |
1575 EYE STREET NW |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
ALLEN M FOX |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 02/19/1985 |
Decision Date | 04/10/1985 |
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
|
|
|