| Device Classification Name |
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
|
| 510(k) Number |
K112769 |
| Device Name |
CURAD COMPRESSION HOSIERY |
| Applicant |
| Medline Industries, Inc. |
| One Medline Place |
|
Mundelein,
IL
60060
|
|
| Applicant Contact |
MATT CLAUSEN |
| Correspondent |
| Medline Industries, Inc. |
| One Medline Place |
|
Mundelein,
IL
60060
|
|
| Correspondent Contact |
MATT CLAUSEN |
| Regulation Number | 880.5780 |
| Classification Product Code |
|
| Date Received | 09/23/2011 |
| Decision Date | 03/01/2012 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|