TRIPTER X-1 COMPACT DUET


Device Classification Name

lithotriptor, extracorporeal shock-wave,urological

510(k) Number K023535
Device Name TRIPTER X-1 COMPACT DUET
Original Applicant
DIREX SYSTEMS CORP.
11 mercer rd.
natick, 
MA 
01760

Original Contact larisa gershtein
Regulation Number 876.5990
Classification Product Code
LNS  
Date Received 10/21/2002
Decision Date 01/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No