Device Classification Name |
electrode, pacemaker, temporary
|
510(k) Number |
K955829 |
Device Name |
SAFPACE SYSTEM |
Applicant |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. |
BETHLEHEM,
PA
18018
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. |
BETHLEHEM,
PA
18018
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 12/26/1995 |
Decision Date | 11/18/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|