AIR-N-GO


Device Classification Name

handpiece, air-powered, dental

510(k) Number K110379
Device Name AIR-N-GO
Applicant
SATELEC
124 gaither drive
suite 140
mt. laurel, 
NJ 
08054

Applicant Contact rick rosati
Correspondent
SATELEC
124 gaither drive
suite 140
mt. laurel, 
NJ 
08054

Correspodent Contact rick rosati
Regulation Number 872.4200
Classification Product Code
EFB  
Date Received 02/10/2011
Decision Date 12/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No