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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 K013687
Device Name NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
Applicant
Steven K. Sue
2065 S. King St.
Suite 304
Honolulu,  HI  96826
Applicant Contact STEVEN K SUE
Correspondent
Steven K. Sue
2065 S. King St.
Suite 304
Honolulu,  HI  96826
Correspondent Contact STEVEN K SUE
Regulation Number872.5570
Classification Product Code
LRK  
Date Received11/07/2001
Decision Date 05/28/2002
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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