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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 Rd.
Boise,  ID  83704
Applicant Contact JAMISON R SPENCER
Correspondent
Craniofacial Pain Center Of Idaho
8119 Ustick Rd.
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
Predetermined Change
Control Plan Authorized		 No
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