DRY MOUTH MOUTHWASH


Device Classification Name

saliva, artificial

510(k) Number K111250
Device Name DRY MOUTH MOUTHWASH
Applicant
DR. FRESH, INC.
medical devices
144 research drive
hampton, 
VA 
23666

Applicant Contact camille thornton
Correspondent
DR. FRESH, INC.
medical devices
144 research drive
hampton, 
VA 
23666

Correspodent Contact camille thornton
Classification Product Code
LFD  
Date Received 05/04/2011
Decision Date 04/27/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No