TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH


Device Classification Name

powered laser surgical instrument

510(k) Number K022655
Device Name TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
Original Applicant
TRIMEDYNE, INC.
15091 bake pkwy.
irvine, 
CA 
92618

Original Contact glenn d yeik
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 08/09/2002
Decision Date 11/07/2002
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