VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH


Device Classification Name

lavage, jet

510(k) Number K110958
Device Name VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
Applicant
SMITH & NEPHEW, INC.
970 lake carillon dr.
suite 110
st. petersburg, 
FL 
33716

Applicant Contact laura reynolds
Correspondent
SMITH & NEPHEW, INC.
970 lake carillon dr.
suite 110
st. petersburg, 
FL 
33716

Correspodent Contact laura reynolds
Regulation Number 880.5475
Classification Product Code
FQH  
Date Received 04/05/2011
Decision Date 08/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No