Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K100909 |
Device Name |
REPROCESSED COMPRESSION SLEEVES |
Applicant |
ASCENT HEALTHCARE SOLUTIONS |
10232 SOUTH 51ST ST. |
PHOENIX,
AZ
85044
|
|
Applicant Contact |
RAMONA KULIK |
Correspondent |
ASCENT HEALTHCARE SOLUTIONS |
10232 SOUTH 51ST ST. |
PHOENIX,
AZ
85044
|
|
Correspondent Contact |
RAMONA KULIK |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 04/01/2010 |
Decision Date | 07/23/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|