Device Classification Name |
Bandage, Elastic
|
510(k) Number |
K013244 |
Device Name |
COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE |
Applicant |
MED GEN, INC. |
7284 W. PALMETTO PK. RD. |
BOCA RATON,
FL
33433 -3406
|
|
Applicant Contact |
THEDORE BARASH |
Correspondent |
MED GEN, INC. |
7284 W. PALMETTO PK. RD. |
BOCA RATON,
FL
33433 -3406
|
|
Correspondent Contact |
THEDORE BARASH |
Regulation Number | 880.5075
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/28/2001 |
Decision Date | 12/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|