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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pad, heating, powered
510(k) Number K160943
Device Name Bite Away
Riemser Pharma
An der Wiek 7
Greifswald-Insel Riems,  DE D-17493
Applicant Contact Ronny Raasch
Quality Systems Resources (QSR)
10807 Dakota Ranch Rd.
Santee,  CA  92071
Correspondent Contact Kenneth K. Kleinhenz
Regulation Number890.5740
Classification Product Code
Date Received04/05/2016
Decision Date 08/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No