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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K153091
Device Name IMPLANT 3D
Applicant
Media Lab S.R.L.
Via Trieste 4
Follo,  IT 19020
Applicant Contact Massimo Ivani
Correspondent
Media Lab S.R.L.
Via Trieste 4
Follo,  IT 19020
Correspondent Contact Massimo Ivani
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/26/2015
Decision Date 02/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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