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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 K202431
Device Name ControlRad Select Model Z
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
IZI   JAA  
Date Received08/25/2020
Decision Date 12/23/2020
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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