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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, fluoroscopic, image-intensified
510(k) Number K173395
Device Name MECALL CLISIS SYSTEMS, Discovery RF180
Applicant
General Medical Merate S.P.A
Via Partigiani, 25
Seriate,  IT 24068
Applicant Contact Luca Bianchessi
Correspondent
Thema SRL
Via Saragat 5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Codes
IZI   KXJ   MQB  
Date Received10/30/2017
Decision Date 05/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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