Device Classification Name |
Negative Pressure Wound Therapy Powered Suction Pump
|
510(k) Number |
K111170 |
FOIA Releasable 510(k) |
K111170
|
Device Name |
PICO |
Applicant |
SMITH & NEPHEW, INC. |
970 LAKE CARILLON DR. |
SUITE 110 |
ST. PETERSBURG,
FL
33716
|
|
Applicant Contact |
TERRY MCMAHON |
Correspondent |
SMITH & NEPHEW, INC. |
970 LAKE CARILLON DR. |
SUITE 110 |
ST. PETERSBURG,
FL
33716
|
|
Correspondent Contact |
TERRY MCMAHON |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 04/26/2011 |
Decision Date | 12/15/2011 |
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
|