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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, Fluoroscopic, Image-Intensified
510(k) Number K121293
Device Name CS-SERIES-FP WITH 3030+OPTION
Applicant
OMEGA MEDICAL IMAGING, LLC
675 HICKMAN CIRCLE
SANFORD,  FL  32771
Applicant Contact BRIAN J FLEMING
Correspondent
OMEGA MEDICAL IMAGING, LLC
675 HICKMAN CIRCLE
SANFORD,  FL  32771
Correspondent Contact BRIAN J FLEMING
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
OWB  
Date Received04/30/2012
Decision Date 07/26/2012
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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