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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact LOUIS P IZZI
Classification Product Code
OBR  
Date Received10/22/2007
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
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