DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K023053
Device Name DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
Original Applicant
SMITH & NEPHEW, INC.
3600 nw 138th st.
oklahoma city, 
OK 
73134

Original Contact steven jackson
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 09/13/2002
Decision Date 10/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No