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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name saliva, artificial
510(k) Number K173237
Device Name Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
Applicant
Syendgen, Inc.
1420 N. Claremont Blvd. Suite 105D
Claremont,  CA  91711
Applicant Contact Shenda Baker
Correspondent
Syendgen, Inc.
1420 N. Claremont Blvd. Suite 105D
Claremont,  CA  91711
Correspondent Contact Christopher Ryan
Classification Product Code
LFD  
Date Received10/05/2017
Decision Date 03/19/2018
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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