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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
Applicant
Biocosmetics Laboratories
57 Lazy Brook Rd.
Monroe,  CT  06468
Applicant Contact Ray Kelly
Correspondent
Biocosmetics Laboratories
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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