Device Classification Name |
Pulse-Generator, Pacemaker, External
|
510(k) Number |
K001180 |
Device Name |
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 |
Applicant |
PACE MEDICAL |
391 TOTTEN POND RD. |
WALTHAM,
MA
02451
|
|
Applicant Contact |
ROBERT C MACE |
Correspondent |
PACE MEDICAL |
391 TOTTEN POND RD. |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
ROBERT C MACE |
Regulation Number | 870.3600
|
Classification Product Code |
|
Date Received | 04/11/2000 |
Decision Date | 06/27/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|