Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K914461 |
Device Name |
A-V IMPULSE SYSTEM |
Applicant |
NOVAMEDIX LTD. |
C/O POWELL-GOLDSTEIN FRAZ-MURP |
1001 PENNSYLVANIA AVE., N.W. |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
THOMAS M ANTONE |
Correspondent |
NOVAMEDIX LTD. |
C/O POWELL-GOLDSTEIN FRAZ-MURP |
1001 PENNSYLVANIA AVE., N.W. |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
THOMAS M ANTONE |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 10/07/1991 |
Decision Date | 04/15/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|