Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K961405 |
Device Name |
ALBA HEALTH PAS WRAP SYSTEM |
Applicant |
ALBA-WALDENSIAN, INC. |
201 ST. GERMAIN AVE., S.W. |
VALDESE,
NC
28690
|
|
Applicant Contact |
VICTOR H GARROU |
Correspondent |
ALBA-WALDENSIAN, INC. |
201 ST. GERMAIN AVE., S.W. |
VALDESE,
NC
28690
|
|
Correspondent Contact |
VICTOR H GARROU |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 04/11/1996 |
Decision Date | 12/26/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|