Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K170814 |
Device Name |
Devon 24 |
Applicant |
Devon Medical Products (Jiangsu) Ltd. |
East Half of 1-2f, Appt D2, 1, Qingfeng Road. |
Nantong,
CN
226017
|
|
Applicant Contact |
Julian Chu |
Correspondent |
Devon Medical Products (Jiangsu) Ltd. |
East Half of 1-2f, Appt D2, 1, Qingfeng Road. |
Nantong,
CN
226017
|
|
Correspondent Contact |
Julian Chu |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 03/17/2017 |
Decision Date | 07/11/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|