SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K022239
Device Name SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
Original Applicant
PRAXIM
49 plain st.
north attleboro, 
MA 
02760

Original Contact sheila hemeon-heyer
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 07/11/2002
Decision Date 08/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No