AIR-FLOW MASTER STANDARD


Device Classification Name

handpiece, air-powered, dental

510(k) Number K073284
Device Name AIR-FLOW MASTER STANDARD
Applicant
(EMS SA) ELECTRO MEDICAL SYSTEMS
49 plain st.
north attleboro, 
MA 
02760

Applicant Contact susan m bonapace
Correspondent
(EMS SA) ELECTRO MEDICAL SYSTEMS
49 plain st.
north attleboro, 
MA 
02760

Correspodent Contact susan m bonapace
Regulation Number 872.4200
Classification Product Code
EFB  
Subsequent Product Code
KOJ  
Date Received 11/21/2007
Decision Date 12/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No