Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K012650 |
Device Name |
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP |
Applicant |
HYGIA HEALTH SERVICES, INC. |
2800 MILAN CT., SUITE 259 |
BIRMINGHAM,
AL
35211
|
|
Applicant Contact |
GEOFF M FATZINGER |
Correspondent |
HYGIA HEALTH SERVICES, INC. |
2800 MILAN CT., SUITE 259 |
BIRMINGHAM,
AL
35211
|
|
Correspondent Contact |
GEOFF M FATZINGER |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 08/13/2001 |
Decision Date | 04/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|