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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 CIRCLE
SUITE 320
STERLING,  VA  20166
Applicant Contact CLYDE A TAKEGUCHI
Correspondent
STRONG DENTAL INC.
21525 RIDGETOP CIRCLE
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
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