V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT


Device Classification Name

negative pressure wound therapy powered suction pump

510(k) Number K111280
Device Name V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
Applicant
KCI USA, INC.
6203 farinon dr.
san antonio, 
TX 
78249

Applicant Contact margaret marsh
Correspondent
KCI USA, INC.
6203 farinon dr.
san antonio, 
TX 
78249

Correspodent Contact margaret marsh
Regulation Number 878.4780
Classification Product Code
OMP  
Date Received 05/06/2011
Decision Date 07/21/2011
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