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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, Mammographic
510(k) Number K023864
Device Name PERFORMA STEREO
Applicant
Instrumentarium Corp. Imaging Division
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Applicant Contact BRIAN BRONCATTI
Correspondent
Instrumentarium Corp. Imaging Division
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Correspondent Contact BRIAN BRONCATTI
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/20/2002
Decision Date 01/09/2003
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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