PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM


Device Classification Name

negative pressure wound therapy powered suction pump

510(k) Number K112127
Device Name PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
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

Correspodent Contact terry mcmahon
Regulation Number 878.4780
Classification Product Code
OMP  
Date Received 07/25/2011
Decision Date 05/16/2012
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