Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K964425 |
Device Name |
A-V IMPULSE SYSTEM MODEL 6060 |
Applicant |
POWELL,GOLDSTEIN,FRAZER & MURPHY |
1001 PENNSYLVANIA AVE, N.W. |
SIXTH FLOOR |
WASINGTON,
DC
20004
|
|
Applicant Contact |
WILLIAM H.E. VON OEHSEN |
Correspondent |
POWELL,GOLDSTEIN,FRAZER & MURPHY |
1001 PENNSYLVANIA AVE, N.W. |
SIXTH FLOOR |
WASINGTON,
DC
20004
|
|
Correspondent Contact |
WILLIAM H.E. VON OEHSEN |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 11/05/1996 |
Decision Date | 07/28/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|