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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mouthguard, prescription
510(k) Number K110468
Device Name FREEWAY COMFORT BITE GUARD
Applicant
RANDMARK DENTAL PRODUCTS, LLC
9109 COPENHAVER DRIVE
POTOMAC,  MD  20854
Applicant Contact NORMAN F ESTRIN
Correspondent
RANDMARK DENTAL PRODUCTS, LLC
9109 COPENHAVER DRIVE
POTOMAC,  MD  20854
Correspondent Contact NORMAN F ESTRIN
Classification Product Code
MQC  
Subsequent Product Code
OBR  
Date Received02/17/2011
Decision Date 08/05/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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