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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 K120552
Device Name AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
Original Applicant
BIOCOSMETICS LABORATORIES
57 lazy brook rd
monroe,  CT  06468
Original Contact ray kelly
Classification Product Code
LFD  
Date Received02/23/2012
Decision Date 06/06/2012
Decision substantially equivalent (SESE)
510k Review Panel Dental
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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