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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, Tomography, Computed
510(k) Number K192590
Device Name CURA 778
Applicant
Fmi Medical Systems, Inc.
29001 Solon Rd., Unit A
Solon,  OH  44139
Applicant Contact Dazhuang Meng
Correspondent
Fmi Medical Systems, Inc.
29001 Solon Rd., Unit A
Solon,  OH  44139
Correspondent Contact Dazhuang Meng
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/20/2019
Decision Date 03/05/2020
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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