Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K223041 |
Device Name |
Renasys Edge (66803126) |
Applicant |
Smith & Nephew Medical Limited |
101 Hessle Road |
Hull,
GB
HU3 2BN
|
|
Applicant Contact |
Zoe Smith |
Correspondent |
Smith & Nephew Medical Limited |
101 Hessle Road |
Hull,
GB
HU3 2BN
|
|
Correspondent Contact |
Zoe Smith |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 09/29/2022 |
Decision Date | 11/22/2022 |
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
|
Recalls |
CDRH Recalls
|