Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K162129 |
Device Name |
RENASYS-G Gauze Dressing Kits with Soft Port |
Applicant |
Smith & Nephew, Inc. |
970 Lake Carillon Drive, Suite 300 |
St Petersburg,
FL
33716
|
|
Applicant Contact |
Laura Reynolds |
Correspondent |
Smith & Nephew, Inc. |
970 Lake Carillon Drive, Suite 300 |
St Petersburg,
FL
33716
|
|
Correspondent Contact |
Laura Reynolds |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 08/01/2016 |
Decision Date | 08/31/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|