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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 K082849
Device Name SILENT SLEEP
Applicant
CRANIOFACIAL PAIN CENTER OF IDAHO
8119 USTICK ROAD
BOISE,  ID  83704
Applicant Contact JAMISON R SPENCER
Correspondent
CRANIOFACIAL PAIN CENTER OF IDAHO
8119 USTICK ROAD
BOISE,  ID  83704
Correspondent Contact JAMISON R SPENCER
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/29/2008
Decision Date 07/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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