DUET MAGNA


Device Classification Name

lithotriptor, extracorporeal shock-wave,urological

510(k) Number K111947
Device Name DUET MAGNA
Applicant
DIREX SYSTEMS CORP.
437 turnpike st.
canton, 
MA 
02021

Applicant Contact larisa gershtein
Correspondent
DIREX SYSTEMS CORP.
437 turnpike st.
canton, 
MA 
02021

Correspodent Contact larisa gershtein
Regulation Number 876.5990
Classification Product Code
LNS  
Date Received 07/08/2011
Decision Date 03/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No