Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K131416 |
Device Name |
NOVOPRESS |
Applicant |
MILKA, LLC |
1425 COACHLITE DRIVE |
GREENFIELD,
IN
46140
|
|
Applicant Contact |
JONATHAN KAHAN |
Correspondent |
MILKA, LLC |
1425 COACHLITE DRIVE |
GREENFIELD,
IN
46140
|
|
Correspondent Contact |
JONATHAN KAHAN |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 05/16/2013 |
Decision Date | 06/23/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|