AIR LIFT/XEROSTOM ARTIFICIAL SALIVA

Saliva, Artificial

BIOCOSMETICS LABORATORIES

The following data is part of a premarket notification filed by Biocosmetics Laboratories with the FDA for Air Lift/xerostom Artificial Saliva.

Pre-market Notification Details

Device IDK120552
510k NumberK120552
Device Name:AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
ClassificationSaliva, Artificial
Applicant BIOCOSMETICS LABORATORIES 57 LAZY BROOK RD Monroe,  CT  06468
ContactRay Kelly
CorrespondentRay Kelly
BIOCOSMETICS LABORATORIES 57 LAZY BROOK RD Monroe,  CT  06468
Product CodeLFD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-23
Decision Date2012-06-06

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