EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE


Device Classification Name

handpiece, air-powered, dental

510(k) Number K022119
Device Name EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
Original Applicant
ELECTRO MEDICAL SYSTEMS SA
49 plain st.
north attleboro, 
MA 
02760

Original Contact mary mcnamara-cullinane
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 07/01/2002
Decision Date 07/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No