Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K052243 |
Device Name |
PROACT WITH GEL OR PROACT 1 |
Applicant |
PROACT INC. |
543 LONG HILL AVENUE |
SHELTON,
CT
06484
|
|
Applicant Contact |
JOSEPH M AZARY |
Correspondent |
PROACT INC. |
543 LONG HILL AVENUE |
SHELTON,
CT
06484
|
|
Correspondent Contact |
JOSEPH M AZARY |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 08/17/2005 |
Decision Date | 04/12/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|