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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