BIOXTRA MOISTURIZING GEL


Device Classification Name

saliva, artificial

510(k) Number K072306
Device Name BIOXTRA MOISTURIZING GEL
Applicant
BIO-X HEALTHCARE S.A.
1601 k street nw
washington, 
DC 
20036

Applicant Contact emalee murphy
Correspondent
BIO-X HEALTHCARE S.A.
1601 k street nw
washington, 
DC 
20036

Correspodent Contact emalee murphy
Classification Product Code
LFD  
Date Received 08/17/2007
Decision Date 11/15/2007
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No