DEGOTZEN SYNCHRO


Device Classification Name

unit, x-ray, extraoral with timer

510(k) Number K021245
Device Name DEGOTZEN SYNCHRO
Original Applicant
THE GOTZEN GROUP, INC.
30 alden terrace
flanders, 
NJ 
07836

Original Contact donald r hill
Regulation Number 872.1800
Classification Product Code
EHD  
Date Received 04/19/2002
Decision Date 05/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No