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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K143176
Device Name UltraLinq
Applicant
ULTRALINQ HEALTHCARE SOLUTIONS, INC.
236 West 30th Street, 15th Floor
new york,  NY  10001
Applicant Contact stephen farber
Correspondent
MethodSense, Inc.
PO Box 110352
durham,  NC  27709
Correspondent Contact rita king
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/04/2014
Decision Date 07/17/2015
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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