PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT


Device Classification Name

negative pressure wound therapy powered suction pump

510(k) Number K121883
Device Name PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
Applicant
KCI USA, INC. (KINETIC CONCEPTS, INC.)
6203 farinon drive
san antonio, 
TX 
78249

Applicant Contact shannon scott
Correspondent
KCI USA, INC. (KINETIC CONCEPTS, INC.)
6203 farinon drive
san antonio, 
TX 
78249

Correspodent Contact shannon scott
Regulation Number 878.4780
Classification Product Code
OMP  
Date Received 06/28/2012
Decision Date 10/11/2012
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