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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 K103416
Device Name NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
Applicant
INFIMED, INC.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
INFIMED, INC.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   MQB  
Date Received11/22/2010
Decision Date 03/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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