Device Classification Name |
Catheter, Recording, Electrode, Reprocessed
|
510(k) Number |
K043513 |
Device Name |
STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER |
Applicant |
STERILMED, INC. |
1140O 73RD AVE. NORTH |
MINNEAPOLIS,
MN
55369
|
|
Applicant Contact |
BRUCE R LESTER |
Correspondent |
STERILMED, INC. |
1140O 73RD AVE. NORTH |
MINNEAPOLIS,
MN
55369
|
|
Correspondent Contact |
BRUCE R LESTER |
Regulation Number | 870.1220
|
Classification Product Code |
|
Date Received | 12/20/2004 |
Decision Date | 03/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|