Device Classification Name |
Negative Pressure Wound Therapy Powered Suction Pump
|
510(k) Number |
K082211 |
Device Name |
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS |
Applicant |
Smith & Nephew, Inc |
970 LAKE CARILLON DRIVE, |
SUITE 110 |
ST. PETERSBURG,
FL
33716
|
|
Applicant Contact |
LAURA KREJCI |
Correspondent |
Smith & Nephew, Inc |
970 LAKE CARILLON DRIVE, |
SUITE 110 |
ST. PETERSBURG,
FL
33716
|
|
Correspondent Contact |
LAURA KREJCI |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 08/06/2008 |
Decision Date | 11/14/2008 |
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
|