Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K152228 |
Device Name |
Hydroven 12, Hydroven 12 Garments |
Applicant |
HUNTLEIGH HEALTHCARE LTD |
35 PORTMANMOOR ROAD |
CARDIFF,
GB
CF24 5HN
|
|
Applicant Contact |
GREG BAILY |
Correspondent |
HUNTLEIGH HEALTHCARE LTD |
35 PORTMANMOOR ROAD |
CARDIFF,
GB
CF24 5HN
|
|
Correspondent Contact |
GREG BAILY |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 08/07/2015 |
Decision Date | 04/04/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|