ENAMELITE ACRYSEAL SPRAY SEALANT

Coating, Filling Material, Resin

ENAMELITE LLC

The following data is part of a premarket notification filed by Enamelite Llc with the FDA for Enamelite Acryseal Spray Sealant.

Pre-market Notification Details

Device IDK093019
510k NumberK093019
Device Name:ENAMELITE ACRYSEAL SPRAY SEALANT
ClassificationCoating, Filling Material, Resin
Applicant ENAMELITE LLC 8708 CAPEHART COVE Austin,  TX  78733
ContactDavid C Furr
CorrespondentDavid C Furr
ENAMELITE LLC 8708 CAPEHART COVE Austin,  TX  78733
Product CodeEBD  
CFR Regulation Number872.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-29
Decision Date2009-12-22
Summary:summary

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