Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K071763 |
Device Name |
AMADEUS ADAPTIVE COMPRESSION THERAPY |
Applicant |
CONVATEC |
200 HEADQUARTERS PARK DR. |
SKILLMAN,
NJ
08558
|
|
Applicant Contact |
MARILYN KONICKY |
Correspondent |
CONVATEC |
200 HEADQUARTERS PARK DR. |
SKILLMAN,
NJ
08558
|
|
Correspondent Contact |
MARILYN KONICKY |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 06/29/2007 |
Decision Date | 03/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|