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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 K122663
Device Name ORAMOIST
Original Applicant
7195 longview drive
cleveland,  OH  44139
Original Contact fred ma
Classification Product Code
Date Received09/17/2012
Decision Date 05/30/2013
Decision substantially equivalent (SE)
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No