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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 K101155
Device Name AURADORM (NEUROMUSCULAR SLEEP)
Applicant
Sleepwright
27 Timberwick Rd.
Santa Fe,  NM  87508
Applicant Contact CYNTHIA WRIGHT
Correspondent
Sleepwright
27 Timberwick Rd.
Santa Fe,  NM  87508
Correspondent Contact CYNTHIA WRIGHT
Regulation Number872.5570
Classification Product Code
LRK  
Date Received04/26/2010
Decision Date 05/12/2011
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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