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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 K170825
Device Name SnoreRx
Apnea Sciences Corporation
27121 Aliso Creek Road, Bldg 140
aliso viejo,  CA  92656
Applicant Contact james fallon
James Smith Ph.D.
24982 Barclay Lane
laguna niguel,  CA  92677
Correspondent Contact james smith
Regulation Number872.5570
Classification Product Code
Date Received03/20/2017
Decision Date 08/18/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No