Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K101330 |
Device Name |
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE |
Applicant |
MIDWEST REPROCESSING CENTER LLC |
434 INDUSTRIAL LANE |
BIRMINGHAM,
AL
35211
|
|
Applicant Contact |
JEROME JAMES |
Correspondent |
MIDWEST REPROCESSING CENTER LLC |
434 INDUSTRIAL LANE |
BIRMINGHAM,
AL
35211
|
|
Correspondent Contact |
JEROME JAMES |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 05/12/2010 |
Decision Date | 08/27/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|