SOMNOMED BFLEX


Device Classification Name

device, anti-snoring

510(k) Number K073004
Device Name SOMNOMED BFLEX
Applicant
SOMNOMED INC.
3537 teasley lane
denton, 
TX 
76210

Applicant Contact ashley truitt
Correspondent
SOMNOMED INC.
3537 teasley lane
denton, 
TX 
76210

Correspodent Contact ashley truitt
Regulation Number 872.5570
Classification Product Code
LRK  
Subsequent Product Code
EBI  
Date Received 10/24/2007
Decision Date 01/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No