Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K152163 |
Device Name |
RENASYS GO |
Applicant |
SMITH & NEPHEW, INC. |
970 LAKE CARILLON DRIVE |
SUITE 110 |
ST. PETERSBURG,
FL
33716
|
|
Applicant Contact |
Laura Reynolds |
Correspondent |
SMITH & NEPHEW, INC. |
970 LAKE CARILLON DRIVE |
SUITE 110 |
ST. PETERSBURG,
FL
33716
|
|
Correspondent Contact |
Laura Reynolds |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 08/03/2015 |
Decision Date | 09/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|