Device Classification Name |
electrode, pacemaker, temporary
|
510(k) Number |
K011660 |
Device Name |
WECK CARDIAC PACING WIRES |
Applicant |
WECK CLOSURE SYSTEMS |
ONE WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Applicant Contact |
BRIAN YOUNG |
Correspondent |
WECK CLOSURE SYSTEMS |
ONE WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Correspondent Contact |
BRIAN YOUNG |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 05/29/2001 |
Decision Date | 08/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|