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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 K102118
Device Name SNORE GUARD ADVANCE
Applicant
Ranir, LLC
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact GERARD J PRUD'HOMME
Correspondent
Ranir, LLC
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact GERARD J PRUD'HOMME
Regulation Number872.5570
Classification Product Code
LRK  
Date Received07/28/2010
Decision Date 09/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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