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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K023836
Device Name THE SUAD DEVICE
Applicant
Strong Dental, Inc.
21525 Ridgetop Cir.
Suite 320
Sterling,  VA  20166
Applicant Contact CLYDE A TAKEGUCHI
Correspondent
Strong Dental, Inc.
21525 Ridgetop Cir.
Suite 320
Sterling,  VA  20166
Correspondent Contact CLYDE A TAKEGUCHI
Regulation Number872.5570
Classification Product Code
LRK  
Date Received11/18/2002
Decision Date 07/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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