Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K143185 |
Device Name |
entré Model PD08-U |
Applicant |
TACTILE SYSTEMS TECHNOLOGY INC |
1331 Tyler St N.E |
MINNEAPOLIS,
MN
55413
|
|
Applicant Contact |
DANIEL G CHASE |
Correspondent |
TACTILE SYSTEMS TECHNOLOGY INC |
1331 Tyler St N.E |
MINNEAPOLIS,
MN
55413
|
|
Correspondent Contact |
DANIEL G CHASE |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 11/05/2014 |
Decision Date | 05/07/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|