Device Classification Name |
electrode, pacemaker, temporary
|
510(k) Number |
K030556 |
Device Name |
STEELEX ELECTRODE SET |
Applicant |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
GEORG KELLER |
Correspondent |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
GEORG KELLER |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 02/21/2003 |
Decision Date | 04/22/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|