Lascod Impression Materials

Material, Impression

Lascod Spa

The following data is part of a premarket notification filed by Lascod Spa with the FDA for Lascod Impression Materials.

Pre-market Notification Details

Device IDK201184
510k NumberK201184
Device Name:Lascod Impression Materials
ClassificationMaterial, Impression
Applicant Lascod Spa Via Longo, 18 Sesto Fiorentino,  IT 50019
ContactGualtiero Cozzi
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-05-01
Decision Date2020-05-05

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