STRESSGARD NIGHTGUARD


Device Classification Name

mouthguard, over-the-counter

510(k) Number K072968
Device Name STRESSGARD NIGHTGUARD
Applicant
TOTALGARD CORPORATION
70 west foster street
melrose, 
MA 
02176

Applicant Contact louis p izzi
Correspondent
TOTALGARD CORPORATION
70 west foster street
melrose, 
MA 
02176

Correspodent Contact louis p izzi
Classification Product Code
OBR  
Date Received 10/22/2007
Decision Date 07/01/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No