POWERLITE 600 EP SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K030423
Device Name POWERLITE 600 EP SYSTEM
Applicant
PRESWEDE AB
55 northern blvd.
suite 200
great neck, 
NY 
11021

Applicant Contact susan goldstein falk
Correspondent
PRESWEDE AB
55 northern blvd.
suite 200
great neck, 
NY 
11021

Correspodent Contact susan goldstein falk
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/10/2003
Decision Date 05/09/2003
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