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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K141454
Device Name SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
Applicant
Sony Electronics, Inc.
62 Forest St., Suite 300
Marlborough,  MA  01752
Applicant Contact JOANNE BRONIKOWSKI
Correspondent
Sony Electronics, Inc.
62 Forest St., Suite 300
Marlborough,  MA  01752
Correspondent Contact JOANNE BRONIKOWSKI
Regulation Number892.2040
Classification Product Code
LMC  
Date Received06/02/2014
Decision Date 06/26/2014
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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