Device Classification Name |
Electrode, Pacemaker, Temporary
|
510(k) Number |
K033858 |
Device Name |
TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE |
Applicant |
EUROPEAN CUSTOM MANUFACTURING BV |
OOST-OM 54 |
NL-5422 VZ |
GEMERT,
NL
|
|
Applicant Contact |
MAARTEN KANTERS |
Correspondent |
EUROPEAN CUSTOM MANUFACTURING BV |
OOST-OM 54 |
NL-5422 VZ |
GEMERT,
NL
|
|
Correspondent Contact |
MAARTEN KANTERS |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 12/11/2003 |
Decision Date | 07/12/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|