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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 K013291
Device Name ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
Applicant
ADVANCED DIAGNOSTICS, INC.
8112 304TH AVE. SE.
PRESTON,  WA  98050
Applicant Contact STEVE HESLER
Correspondent
ADVANCED DIAGNOSTICS, INC.
8112 304TH AVE. SE.
PRESTON,  WA  98050
Correspondent Contact STEVE HESLER
Regulation Number892.1550
Classification Product Code
NCS  
Date Received10/02/2001
Decision Date 11/14/2001
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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