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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 K111344
Device Name I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
Applicant
INFIMED, INC.
121 METROPOLITAN DR.
LIVERPOOL,  NY  13088
Applicant Contact CATHERINE MULCAHY
Correspondent
INFIMED, INC.
121 METROPOLITAN DR.
LIVERPOOL,  NY  13088
Correspondent Contact CATHERINE MULCAHY
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received05/12/2011
Decision Date 06/10/2011
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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