GELX ORAL GEL


Device Classification Name

dressing, wound and burn, hydrogel w/drug and/or biologic

510(k) Number K081372
Device Name GELX ORAL GEL
Applicant
BMG PHARMA LLC.
824 highway 88
gardnerville, 
NV 
89460

Applicant Contact william a goolsbee
Correspondent
BMG PHARMA LLC.
824 highway 88
gardnerville, 
NV 
89460

Correspodent Contact william a goolsbee
Classification Product Code
MGQ  
Date Received 05/16/2008
Decision Date 02/04/2009
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No