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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 K171755
Device Name CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
Applicant
Omega Medical Imaging, LLC
675 Hickman Circle
Sanford,  FL  32771
Applicant Contact John Newman
Correspondent
Omega Medical Imaging, LLC
675 Hickman Circle
Sanford,  FL  32771
Correspondent Contact John Newman
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received06/13/2017
Decision Date 02/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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