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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 K022627
Device Name DSG RELAXER SPLINT
Applicant
Sentage Corporation D/B/A/ Dental Services Group
1801 K St. NW
Suite 1200
Washington,  DC  20006
Applicant Contact G. BRENT CONNOR
Correspondent
Sentage Corporation D/B/A/ Dental Services Group
1801 K St. NW
Suite 1200
Washington,  DC  20006
Correspondent Contact G. BRENT CONNOR
Classification Product Code
MQC  
Date Received08/07/2002
Decision Date 03/18/2003
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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