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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 K172760
Device Name REST EAZY Appliance
Applicant
Insert Molding Solutions, Inc.
4325 Settingdown Circle, Suite 103
Cumming,  GA  30028
Applicant Contact Paul Hendrixson
Correspondent
Regulatory and Quality Solutions, LLC
2790 Mosside Blvd #800
Monroeville,  PA  15146
Correspondent Contact Felicia Ruley
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/13/2017
Decision Date 03/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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