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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 K200663
Device Name ControlRad Trace Model 9
Applicant
ControlRad, Inc.
275 Scientific Drive NW #1100
Norcross,  GA  30092
Applicant Contact Chris Fair
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Highway, Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received03/13/2020
Decision Date 06/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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