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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 K051014
Device Name SILENT PARTNER SERIES OSA APPLIANCES
Applicant
DREAMWRX DENTAL LABORATORY
1911 COLORADO BLVD.
LOS ANGELES,  CA  90041
Applicant Contact NICOLAAS BESSELING
Correspondent
DREAMWRX DENTAL LABORATORY
1911 COLORADO BLVD.
LOS ANGELES,  CA  90041
Correspondent Contact NICOLAAS BESSELING
Regulation Number872.5570
Classification Product Code
LRK  
Date Received04/21/2005
Decision Date 08/09/2005
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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