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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, Tomography, Computed
510(k) Number K151414
Device Name IQQA Guide
Applicant
Edda Technology
5 Independence Way
Princeton,  NJ  08540
Applicant Contact XIAOLAN ZENG
Correspondent
Edda Technology
5 Independence Way
Princeton,  NJ  08540
Correspondent Contact DANIEL KAMM
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/27/2015
Decision Date 11/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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