Device Classification Name |
electrode, pacemaker, temporary
|
510(k) Number |
K963073 |
Device Name |
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET |
Applicant |
HARMAC MEDICAL PRODUCTS, INC. |
2201 BAILEY AVE. |
BUFFALO,
NY
14211 -1797
|
|
Applicant Contact |
JOSEPH M KONIECZNY |
Correspondent |
HARMAC MEDICAL PRODUCTS, INC. |
2201 BAILEY AVE. |
BUFFALO,
NY
14211 -1797
|
|
Correspondent Contact |
JOSEPH M KONIECZNY |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 06/28/1996 |
Decision Date | 08/14/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|