Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K132446 |
Device Name |
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE |
Applicant |
SMITH & NEPHEW, INC. |
970 LAKE CARILLON DR. |
SUITE 110 |
ST. PETERSBURG,
FL
33716
|
|
Applicant Contact |
LAURA REYNOLDS |
Correspondent |
SMITH & NEPHEW, INC. |
970 LAKE CARILLON DR. |
SUITE 110 |
ST. PETERSBURG,
FL
33716
|
|
Correspondent Contact |
LAURA REYNOLDS |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 08/06/2013 |
Decision Date | 10/23/2013 |
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 |
No
|
Recalls |
CDRH Recalls
|