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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 K153200
Device Name SnoreRx
Applicant
Apnea Sciences Corporation
27121 Aliso Creek Rd., Bldg. 140
Aliso Viejo,  CA  92656
Applicant Contact James Fallon
Correspondent
Apnea Sciences Corporation
29442 Pt.e Royale
Laguna Niguel,  CA  92677
Correspondent Contact James Smith
Regulation Number872.5570
Classification Product Code
LRK  
Date Received11/04/2015
Decision Date 08/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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