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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K192182
Device Name C015
Applicant
Micronica Srl
Via Augusto Righi, 30
Mirandola,  IT 41037
Applicant Contact Massimo Tomasi
Correspondent
THEMA S.r.l.
Via Saragat,5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   LMC   OXO  
Date Received08/12/2019
Decision Date 01/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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