Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K120972 |
Device Name |
FLEXITOUCH SYSTEM |
Applicant |
TACTILE SYSTEMS TECHNOLOGY INC |
1331 Tyler St NE Ste 200 |
MINNEAPOLIS,
MN
55413
|
|
Applicant Contact |
PHILLIP ROSE |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 04/02/2012 |
Decision Date | 04/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|