SOMNOGUARD SP SOFT


Device Classification Name

device, anti-snoring

510(k) Number K121761
Device Name SOMNOGUARD SP SOFT
Applicant
TOMED DR. TOUSSAINT GMBH
854 us route 3
holderness, 
NH 
03245

Applicant Contact scott whitcomb
Correspondent
TOMED DR. TOUSSAINT GMBH
854 us route 3
holderness, 
NH 
03245

Correspodent Contact scott whitcomb
Regulation Number 872.5570
Classification Product Code
LRK  
Date Received 06/15/2012
Decision Date 09/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No