Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K992454 |
Device Name |
VENAFLOW SYSTEM, MODEL 30A |
Applicant |
AIRCAST, INC. |
92 RIVER RD. |
SUMMIT,
NJ
07902
|
|
Applicant Contact |
STEPHEN KENNEY |
Correspondent |
AIRCAST, INC. |
92 RIVER RD. |
SUMMIT,
NJ
07902
|
|
Correspondent Contact |
STEPHEN KENNEY |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 07/23/1999 |
Decision Date | 01/13/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|