Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K961676 |
Device Name |
AIRCAST VENAFLOW SYSTEM (MODIFICATION) |
Applicant |
AIRCAST, INC. |
P.O. BOX 709 |
92 RIVER ROAD |
SUMMIT,
NJ
07902 -0709
|
|
Applicant Contact |
STEPHEN L KENNEY |
Correspondent |
AIRCAST, INC. |
P.O. BOX 709 |
92 RIVER ROAD |
SUMMIT,
NJ
07902 -0709
|
|
Correspondent Contact |
STEPHEN L KENNEY |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 04/12/1996 |
Decision Date | 03/28/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|