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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Salivary System
510(k) Number K180838
Device Name SaliPen
Applicant
Saliwell , Ltd.
65 Hatamar St.
Harutzim,  IL 6091700
Applicant Contact Ben Z. Beiski
Correspondent
Saliwell , Ltd.
65 Hatamar St.
Harutzim,  IL 6091700
Correspondent Contact Ben Z. Beiski
Regulation Number872.5560
Classification Product Code
LTF  
Date Received03/30/2018
Decision Date 11/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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