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