VENX REVOLUTION


Device Classification Name

stylet, surgical, general & plastic surgery

510(k) Number K110355
Device Name VENX REVOLUTION
Applicant
VENX LLC
4700 s. overland drive
tucson’, 
AZ 
85714

Applicant Contact ira duesler
Correspondent
VENX LLC
4700 s. overland drive
tucson’, 
AZ 
85714

Correspodent Contact ira duesler
Regulation Number 878.4800
Classification Product Code
GAH  
Date Received 02/07/2011
Decision Date 04/22/2011
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