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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K201184
Device Name Lascod Impression Materials
Applicant
Lascod Spa
Via Longo, 18
Sesto Fiorentino,  IT 50019
Applicant Contact Gualtiero Cozzi
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.3660
Classification Product Code
ELW  
Date Received05/01/2020
Decision Date 05/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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