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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 K132342
Device Name XVWEB
Applicant
APTERYX, INC.
313 S HIGH ST.
SUITE 200
Akron,  OH  44308
Applicant Contact KEVIN CRUCS
Correspondent
APTERYX, INC.
313 S HIGH ST.
SUITE 200
Akron,  OH  44308
Correspondent Contact KEVIN CRUCS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/26/2013
Decision Date 12/20/2013
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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