Device Classification Name |
Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
|
510(k) Number |
K053188 |
Device Name |
REPROCESSED BALOON INFLATION DEVICE |
Applicant |
STERILMED, INC. |
11400 73RD AVE. NORTH |
MAPLE GROVE,
MN
55369
|
|
Applicant Contact |
BRUCE R LESTER |
Correspondent |
STERILMED, INC. |
11400 73RD AVE. NORTH |
MAPLE GROVE,
MN
55369
|
|
Correspondent Contact |
BRUCE R LESTER |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 11/15/2005 |
Decision Date | 05/04/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|