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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Holography, Acoustic
510(k) Number K013886
Device Name AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
Applicant
Advanced Diagnostics, Inc.
8112 304th Ave. Se.
Preston,  WA  98050
Applicant Contact STEVE HESSLER
Correspondent
Advanced Diagnostics, Inc.
8112 304th Ave. Se.
Preston,  WA  98050
Correspondent Contact STEVE HESSLER
Regulation Number892.1550
Classification Product Code
NCS  
Date Received11/23/2001
Decision Date 05/10/2002
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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