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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 K981923
Device Name THE SNORE PEACE
Applicant
The Snore Peace Group
24791 Via San Felipe
Mission Viejo,  CA  92692
Applicant Contact DAVID V SHEEHAN
Correspondent
The Snore Peace Group
24791 Via San Felipe
Mission Viejo,  CA  92692
Correspondent Contact DAVID V SHEEHAN
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/01/1998
Decision Date 08/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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