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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 K073446
Device Name GRIND GUARD
Applicant
ARCHTEK, INC.
1705 SOUTH CAPITOL OF TEXAS HW
AUSTIN,  TX  78746
Applicant Contact IAN P GORDON
Correspondent
ARCHTEK, INC.
1705 SOUTH CAPITOL OF TEXAS HW
AUSTIN,  TX  78746
Correspondent Contact IAN P GORDON
Classification Product Code
OBR  
Date Received12/07/2007
Decision Date 02/08/2008
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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